----------------------------------------------------------------------------------------------------------------
                                  Yakima Regional Clean Air Agency Regulations
                                 Article I--Policy, Short Title and Definitions
----------------------------------------------------------------------------------------------------------------
1.01..................  Policy.............     12/15/95  2/2/98, 63 FR 5269................
1.02..................  Short Title........     11/18/93  2/2/98, 63 FR 5269................
1.03..................  Definitions........     12/15/95  2/2/98, 63 FR 5269................
----------------------------------------------------------------------------------------------------------------
                                         Article II--General Provisions
----------------------------------------------------------------------------------------------------------------
2.02..................  Control Officer-        11/18/93  2/2/98, 63 FR 5269................
                         Powers & Duties.
2.03..................  Miscellaneous           11/18/93  2/2/98, 63 FR 5269................
                         Provisions.
2.04..................  Confidentiality....     11/18/93  2/2/98, 63 FR 5269................
2.05..................  Advisory Council...     11/18/93  2/2/98, 63 FR 5269................
----------------------------------------------------------------------------------------------------------------
                                  Article III--Violations--Orders and Hearings
----------------------------------------------------------------------------------------------------------------
3.01..................  Notice of               11/18/93  2/2/98, 63 FR 5269................
                         Violation--Correct
                         ive Action
                         Hearings.
3.02..................  Finality of Order..     11/18/93  2/2/98, 63 FR 5269................
3.03..................  Stay of Order           11/18/93  2/2/98, 63 FR 5269................
                         Pending Appeal.
3.04..................  Voluntary               11/18/93  2/2/98, 63 FR 5269................
                         Compliance.
----------------------------------------------------------------------------------------------------------------
                               Article IV--Registration and Notice of Construction
----------------------------------------------------------------------------------------------------------------
4.01..................  Registration.......     12/15/95  2/2/98, 63 FR 5269................
4.02..................  Notice of               12/15/95  2/2/98, 63 FR 5269................
                         Construction.
4.03..................  Exceptions to           11/18/93  2/2/98, 63 FR 5269................
                         Article 4.
----------------------------------------------------------------------------------------------------------------
                            Article V--Emissions Standards and Preventative Measures
----------------------------------------------------------------------------------------------------------------
5.01..................  Outdoor Burning....     12/15/95  2/2/98, 63 FR 5269................
5.02..................  Regulations             12/15/95  2/2/98, 63 FR 5269................
                         Applicable to all
                         Outdoor Burning.

5.03..................  Regulations             12/15/95  2/2/98, 63 FR 5269................
                         Applicable to all
                         Outdoor Burning
                         within
                         Jurisdiction of
                         the Yakima County
                         Clean Air
                         Authority, Local
                         Cities, Towns,
                         Fire Protection
                         Districts and
                         Conservation
                         Districts.
5.04..................  Regulations             12/15/95  2/2/98, 63 FR 5269................
                         Applicable to
                         Permits Issued by
                         the Yakima County
                         Clean Air
                         Authority for all
                         Other Outdoor
                         Burning.
5.05..................  Additional              12/15/95  2/2/98, 63 FR 5269................
                         Restrictions on
                         Outdoor Burning.
5.06..................  General Standards       12/15/95  2/2/98, 63 FR 5269................
                         for Maximum
                         Permissible
                         Emissions.
5.07..................  Minimum Emission        12/15/95  2/2/98, 63 FR 5269................
                         Standards for
                         Combustion and
                         Incineration
                         Sources.
5.08..................  Minimum Emissions       12/15/95  2/2/98, 63 FR 5269................
                         Standards for
                         General Process
                         Sources.
5.10..................  Sensitive Area           6/20/94  2/2/98, 63 FR 5269................
                         Designation.
5.11..................  Monitoring and          12/15/95  2/2/98, 63 FR 5269................
                         Special Reporting.
5.12..................  Preventive Measures     11/18/93  2/2/98, 63 FR 5269................
----------------------------------------------------------------------------------------------------------------
                                     Article VIII--Penalty and Severability
----------------------------------------------------------------------------------------------------------------
8.01..................  Penalty for             11/18/93  2/2/98, 63 FR 5269................
                         Violation.
8.02..................  Additional/             12/15/95  2/2/98, 63 FR 5269................
                         Alternative
                         Penalties.
8.03..................  Assurance of            11/18/93  2/2/98, 63 FR 5269................
                         Discontinuance.
8.04..................  Restraining Order--     11/18/93  2/2/98, 63 FR 5269................
                         Injunctions.
8.05..................  Severability.......     12/15/95  2/2/98, 63 FR 5269................
----------------------------------------------------------------------------------------------------------------
                                      Article IX--Woodstoves and Fireplaces
----------------------------------------------------------------------------------------------------------------
9.01..................  Policy.............     11/18/93  2/2/98, 63 FR 5269................
9.02..................  Opacity............     11/18/93  2/2/98, 63 FR 5269................
9.03..................  Prohibitive Fuel        11/18/93  2/2/98, 63 FR 5269................
                         Types.
9.04..................  Limitations of          11/18/93  2/2/98, 63 FR 5269................
                         Sales of Solid
                         Fuel Burning
                         Devices.
9.05..................  Prohibition of          12/15/95  2/2/98, 63 FR 5269................
                         Visible Emissions
                         During Air
                         Pollution Episodes.
----------------------------------------------------------------------------------------------------------------
                             Article XII--Adoption of State and Federal Regulations
----------------------------------------------------------------------------------------------------------------
12.01.................  State Regulations..     12/15/95  2/2/98, 63 FR 5269................
----------------------------------------------------------------------------------------------------------------
                                  Article XIII--Fee Schedules and Other Charges
----------------------------------------------------------------------------------------------------------------
13.01.................  Registration and         1/13/94  2/2/98, 63 FR 5269................
                         Fee Schedule.
13.02.................  Notice of                6/20/94  2/2/98, 63 FR 5269................
                         Construction Fee
                         Schedule.
13.03.................  Outdoor Burning          6/20/94  2/2/98, 63 FR 5269................
                         Permit Fees.
----------------------------------------------------------------------------------------------------------------
                                  Washington Department of Ecology Regulations
         Washington Administrative Code, Chapter 173-400--General Regulations for Air Pollution Sources
----------------------------------------------------------------------------------------------------------------
173-400-010...........  Policy and Purpose.      3/22/91  6/2/95, 60 FR 28726...............
173-400-020...........  Applicability......      3/22/91  6/2/95, 60 FR 28726...............
173-400-030...........  Definitions........      3/22/91  6/2/95, 60 FR 28726...............
173-400-040...........  General Standards        3/22/91  6/2/95, 60 FR 28726...............  Except (1)(c), and
                         for Maximum                                                           (1)(d), (2), (4),
                         Emissions.                                                            and the 2nd
                                                                                paragraph of (6).
173-400-050...........  Emission Standards       3/22/91  6/2/95, 60 FR 28726...............  Except the
                         for Combustion and                                                    exception
                         Incineration Units.                                                   provision in (3).
173-400-060...........  Emission Standards       3/22/91  6/2/95, 60 FR 28726...............
                         for General
                         Process Units.
173-400-070...........  Emission Standards       3/22/91  6/2/95, 60 FR 28726...............  Except (7).
                         for Certain Source
                         Categories.
173-400-081...........  Startup and              9/20/93  6/2/95, 60 FR 28726...............
                         Shutdown.
173-400-091...........  Voluntary Limits on      9/20/93  6/2/95, 60 FR 28726...............  9/20/93 version
                         Emissions.                                                            continues to be
                                                                                approved under
                                                                                the authority of
                                                                                CAA Section
                                                                                112(l) with
                                                                                respect to
                                                                                Section 112
                                                                                hazardous air
                                                                                pollutants. See
                                                                                the Federal
                                                                                Register of June
                                                                                2, 1995.
173-400-100...........  Registration.......      9/20/93  6/2/95, 60 FR 28726...............
173-400-105...........  Records, Monitoring      9/20/93  6/2/95, 60 FR 28726...............
                         and Reporting.
173-400-107...........  Excess Emissions...      9/20/93  6/2/95, 60 FR 28726...............
173-400-110...........  New Source Review        9/20/93  6/2/95, 60 FR 28726...............
                         (NSR).
173-400-112...........  Requirements for         9/20/93  6/2/95, 60 FR 28726...............  Except (8).
                         New Sources in
                         Nonattainment
                         Areas.
173-400-113...........  Requirements for         9/20/93  6/2/95, 60 FR 28726...............  Except (5).
                         New Sources in
                         Attainment or
                         Unclassifiable
                         Areas.
173-400-151...........  Retrofit                 3/22/91  6/2/95, 60 FR 28726...............
                         Requirements for
                         Visibility
                         Protection.
173-400-161...........  Compliance               3/22/91  6/2/95, 60 FR 28726...............
                         Schedules.
173-400-171...........  Public Involvement.      9/20/93  6/2/95, 60 FR 28726...............

173-400-190...........  Requirements for         3/22/91  6/2/95, 60 FR 28726...............
                         Nonattainment
                         Areas.
173-400-200...........  Creditable Stack         3/22/91  6/2/95, 60 FR 28726...............
                         Height &
                         Dispersion
                         Techniques.
173-400-205...........  Adjustment for           3/22/91  6/2/95, 60 FR 28726...............
                         Atmospheric
                         Conditions.
173-400-210...........  Emission                 3/22/91  6/2/95, 60 FR 28726...............
                         Requirements of
                         Prior
                         Jurisdictions.
----------------------------------------------------------------------------------------------------------------

    (d) EPA-approved state source-specific requirements.

                                            EPA-Approved State of Washington Source-Specific Requirements \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
           Name of source                Order/permit No.         State effective date        EPA approval date                 Explanations
--------------------------------------------------------------------------------------------------------------------------------------------------------
Boise Cascade, Wallula Mill.........  1614-AQ04.............  9/15/04....................  5/2/05, 70 FR 22597...  Following conditions only: No. 1
                                                                                (Approval Conditions) & Appendix A.
Emission Limits for Significant       various orders........  various dates..............  10/26/95, 60 FR 54812.
 Stack Sources.
Honam, Inc., Ideal Division (now      #5183.................  2/9/94.....................  8/31/04, 69 FR 53007..
 known as LaFarge North America,
 Inc.).
Saint Gobain Containers LLC.........  #8244.................  9/9/99.....................  8/31/04, 69 FR 53007..
Kaiser Order--Alternate Opacity       91-01.................  12/12/91...................  1/27/97, 62 FR 3800...
 Limit.
Kaiser Order--Limiting Potential-to-  96-03.................  10/4/00....................  7/1/05, 70 FR 38029...
 Emit.
Kaiser Order--Limiting Potential-to-  96-04.................  4/24/96....................  1/27/97, 62 FR 3800...
 Emit.
Kaiser Order--Limiting Potential-to-  96-05.................  10/4/00....................  7/1/05, 70 FR 38029...
 Emit.
Kaiser Order--Limiting Potential-to-  96-06.................  10/19/00...................  7/1/05, 70 FR 38029...
 Emit.
RACT Limits for Centralia Power       #97-2057R1............  2/26/98....................  6/11/03, 68 FR 34821..
 Plant.
BP Cherry Point Refinery............  Administrative Order    5/13/15....................  2/16/16, 81 FR 7710...  The following conditions: 1.1, 1.1.1,
                                       No. 7836, Revision 2.                                                        1.2, 1.2.1,1.2.2, 2.1, 2.1.1, 2.1.2,
                                                                                2.1.3, 2.1.4, 2.1.5, 2.2, 2.2.1,
                                                                                2.2.2, 2.3, 2.3.1, 2.3.2, 2.4,
                                                                                2.4.1, 2.4.2, <IP_ADDRESS>, 2.5, 2.5.1,
                                                                                <IP_ADDRESS>, <IP_ADDRESS>, 2.5.2, 2.5.3,
                                                                                2.5.4, 2.6, 2.6.1, 2.6.2, 2.6.3,
                                                                                2.7, 2.7.1, 2.7.2, 2.7.3, 2.7.4,
                                                                                2.8, 2.8.1, 2.8.2, 2.8.3, 2.8.4,
                                                                                2.8.5, 2.8.6, 3, 3.1, 3.1.1,3.1.2,
                                                                                3.2, 3.2.1, 3.2.2, 3.2.3, 3.2.4, 4,
                                                                                4.1, 4.1.1, <IP_ADDRESS>, <IP_ADDRESS>,
                                                                                <IP_ADDRESS>, <IP_ADDRESS>, 5, 5.1, 5.2, 6,
                                                                                6.1, 6.2, 6.3, 7, 9.
Alcoa Intalco Works.................  Administrative Order    11/15/10...................  6/11/14, 79 FR 33438..  The following conditions: 1, 2., 2.1,
                                       No. 7837, Revision 1.                                                        3., 4., 4.1, Attachment A
                                                                                conditions: A1, A2, A3, A4, A5, A6,
                                                                                A7, A8, A9, A10, A11, A12, A13, A14.

Tesoro Refining and Marketing         Administrative Order    7/7/10.....................  6/11/14, 79 FR 33438..  The following conditions: 1., 1.1,
 Company.                              7838.                                                                        1.1.1, 1.1.2, 1.2, 1.3, 1.4, 1.5,
                                                                                1.5.1, <IP_ADDRESS>,<IP_ADDRESS>, <IP_ADDRESS>,
                                                                                1.5.2, 1.5.3, 1.5.4, 1.5.5, 1.5.6,
                                                                                2., 2.1, 2.1.1, <IP_ADDRESS>, 2.1.2,
                                                                                2.1.3, 2.2, 2.2.1, 3. 3.1, 3.1.1,
                                                                                3.1.2, <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>,
                                                                                3.2, 3.2.1, <IP_ADDRESS>, <IP_ADDRESS>,
                                                                                <IP_ADDRESS>, <IP_ADDRESS>, <IP_ADDRESS>.1,
                                                                                <IP_ADDRESS>.2, <IP_ADDRESS>.3, <IP_ADDRESS>.4,
                                                                                <IP_ADDRESS>.5, 3.3, 3.3.1, 3.4, 3.4.1,
                                                                                3.4.2, 4., 4.1, 5., 5.1, 6., 6.1,
                                                                                6.1.1, 6.1.2, 6.1.3, 6.1.4, 7., 7.1,
                                                                                7.1.1, 7.1.2, 7.1.3, 7.1.4, 7.1.5,
                                                                                7.2, 7.2.1, 7.2.2, 7.2.3, 7.2.4, 8.
                                                                                8.1, 8.1.1, 8.1.2, 8.2, 8.2.1,
                                                                                8.2.2, 8.2.3, 8.3, 8.3.1, 8.3.2, 9.,
                                                                                9.1, 9.1.1, 9.1.2, 9.2, 9.2.1,
                                                                                <IP_ADDRESS>, 9.3.2, 9.3.3,9.4, 9.4.1,
                                                                                9.4.2, 9.4.3, 9.4.5, 9.4.6, 9.5, 10,
                                                                                11, 12, 13, 13.1, 13.2, 13.3, 13.4,
                                                                                13.5, 13.6.
Port Townsend Paper Corporation.....  Administrative Order    10/20/10...................  6/11/14, 79 FR 33438..  The following Conditions:1, 1.1, 1.2,
                                       No. 7839, Revision 1.                                                        1.3, 2, 2.1, 3, 3.1, 4.
Lafarge North America, Inc. Seattle,  Administrative Revised  7/28/10....................  6/11/14, 79 FR 33438..  The following Conditions: 1, 1.1,
 Wa.                                   Order No. 7841.                                                              1.2, 2, 2.1, 2.1.1, 2.1.2, 2.2, 2.3,
                                                                                3, 3.1, 3.1.1, 3.1.2, 3.1.3, 3.2,
                                                                                3.3, 4, 4.1, 5, 5.1, 5.1.1, 5.1.2,
                                                                                5.2, 5.3, 6, 6.1, 7, 7.1, 7.2, 7.3,
                                                                                7.4, 7.5, 8, 8.1, 8.2, 8.3, 8.4,
                                                                                8.5, 9, 10, 11, 12.
Weyerhaeuser Corporation, Longview,   Administrative Order    7/7/10.....................  6/11/14, 79 FR 33438..  The following Conditions: 1, 1.1,
 Wa.                                   No. 7840.                                                                    1.1.1, 1.1.2, 1.1.3, 1.2, 1.2.1,
                                                                                1.2.2, 1.2.3, 1.3, 1.3.1, 1.4, 2,
                                                                                2.1, 3, 3.1, 4, 4.1.
Tyson Fresh Meats, Inc..............  13AQ-E526.............  4/16/14....................  5/1/20, 85 FR 25306...  Except:
                                                                                1. Decontamination Cabinets;
                                                                                2. Meat Cutting/Packing;
                                                                                6. Wastewater Floatation;
                                                                                8. Utility Equipment;
                                                                                10. Other;
                                                                                References to ``WAC 173-460-040'' in
                                                                                Determinations'';
                                                                                The portion of Approval Condition 2.a
                                                                                which states, ``and consumption of
                                                                                no more than 128 million cubic feet/
                                                                                of natural gas per year. Natural gas
                                                                                consumption records for the dryer
                                                                                shall be maintained for the most
                                                                                recent 24 month period and be
                                                                                available to Ecology for inspection.
                                                                                An increase in natural gas
                                                                                consumption that exceeds the above
                                                                                level may require a Notice of
                                                                                Construction.'';
                                                                                Approval Condition 3;
                                                                                Approval Condition 4;
                                                                                Approval Condition 5;
                                                                                Approval Condition 6.e;
                                                                                Approval Condition 9.a.ii;
                                                                                Approval Condition 9.a.iv;
                                                                                Approval Condition 9.a.v;
                                                                                Approval Condition 9.a.vi;
                                                                                Approval Condition 10.a.ii;
                                                                                Approval Condition 10.b;
                                                                                Approval Condition 11.a;
                                                                                Approval Condition 11.b;
                                                                                Approval Condition 11.e;
                                                                                Approval Condition 12;
                                                                                Approval Condition 15;
                                                                                The section titled ``Your Right to
                                                                                Appeal''; and
                                                                                The section titled ``Address and
                                                                                Location Information.''
Packaging Corporation of America      0003697...............  4/1/18.....................  5/1/20, 85 FR 25306...  Condition P.1 only.
 (Wallula Mill).
Simplot Feeders Limited Partnership.  Fugitive Dust Control   3/1/18.....................  5/1/20, 85 FR 25306...
                                       Plan.
TransAlta Centralia BART--Second      #6426.................  7/29/20....................  5/7/21, 86 FR 24502...  Except the undesignated introductory
 Revision.                                                                                text, the section titled
                                                                                ``Findings,'' and the undesignated
                                                                                text following condition 9.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The EPA does not have the authority to remove these source-specific requirements in the absence of a demonstration that their removal would not
  interfere with attainment or maintenance of the NAAQS, violate any prevention of significant deterioration increment or result in visibility
  impairment. Washington Department of Ecology may request removal by submitting such a demonstration to the EPA as a SIP revision.

* * * * *
[FR Doc. 2021-15878 Filed 8-2-21; 8:45 am]
BILLING CODE 6560-50-P


Call w/John Durkee,<PHONE_NUMBER>

5/30/2007

Q1) Why does it matter?  What does SNAP apply to?  (if not currently
using ODS)

Would like some justification.

Q2) Why not start over with a requirement for an AEL?  Won’t allow to
start over.

A: We would need a significant increase in risk to justify this for
solvents.  We take comment on it in the proposal for aerosols/adhesives.

3) Why not regulate as HAP?  A:  It’s a statutory list.  Would need a
petition from the public.

Aerosols –nPB is unacceptable (proposal).

Mr. Durkee is concerned about handwipe applications and people misusing
nPB (receiving excessive exposure).

Mr. Durkee has been looking at cleaning performance of alternatives to
nPB that are VOC exempt.

Methyl acetate & water (VOC exempt)

TBAC & water (VOC exempt)

Propylene glycol ether

Heptane & water

Justification

III.D.1.b  59 FR 13048

b.	Review of Existing versus New Substitutes

	A number of commenters believed that EPA's SNAP program has no
authority to restrict existing substitutes, which companies may have
switched to in an effort to eliminate the use of CFCs prior to the
publication of this final rule.  Arguments in support of this position
include the prospective language of the statute, which says EPA must
make it "unlawful to replace" an ODS with a substitute deemed
unacceptable.  Many of these commenters recommended grandfathering of
these existing uses, so as not to disrupt industry's transition away
from ODSs.  An extension of this concern appears in several comments, in
which commenters expressed the fear that SNAP will revisit prior
decisions, removing substitutes previously deemed acceptable as newer
and more environmentally benign substitutes are developed.

	Under the Agency's interpretation of section 612, in order to fulfill
the Congressional mandate to review "any" substitute substance that may
present adverse effects to human health and the environment, both new
and existing substitutes must be included under SNAP.  In addition,
section 612(e) specifically requires notifying the Agency before new or
existing chemicals are introduced into interstate commerce.  EPA
believes that class I and II substances are "replaced" within the
meaning of section 612(c) each time a substitute is used, so that once
EPA identifies an unacceptable substitute, any future use of such
substitute is prohibited.  Under any other interpretation, EPA could
never effectively prohibit the use of any substitute, as some user could
always start to use it prior to EPA's completion of the rulemaking
required to list it as unacceptable.  EPA believes Congress could not
have intended such a result, and must therefore have intended to cover
future use of existing substitutes.

Section IV.A.2.f & g

f.	Second-Generation Substitutes  59 FR 13052

	A key issue is whether there exists a point at which an alternative
should no longer be considered a class I or II substitute as defined by
section 612.  The Agency believes that as long as class I or II
chemicals are being used, any substitute designed to replace these
chemicals is subject to review under section 612.  In this final rule,
the Agency has determined that second-generation replacements, if they
are non-ozone depleting and are replacing non-ozone depleting
first-generation alternatives, are exempt from reporting requirements
under section 612.  Other regulatory programs (e.g., other sections of
the CAA, or section 6 of TSCA) exist to ensure protection of human
health and the environment in these situations.

	Where second-generation substitutes replace first-generation
substitutes that are themselves ozone-depleters (e.g., HCFCs), these
second-generation substitutes are bound by the same notification and
review requirements under section 612 as first-generation substitutes to
ozone-depleting chemicals.  For example, if a hydrofluorocarbon (HFC) is
introduced as a first-generation refrigerant substitute for either a
class I (e.g., CFC-12) or class II chemical (e.g., HCFC-22), it is
subject to review and listing under section 612.  Future substitutions
to replace the HFC would then be exempt from reporting under section 612
because the first-generation alternative did not deplete stratospheric
ozone.  If, however, a class I or class II chemical is used as a
first-generation substitute (e.g., use of HCFC-141b as a transitional
replacement in foam blowing), the second-generation substitute is still
subject to review under section 612 because it is replacing a class I or
class II chemical.

	The key to determining whether a substitute is exempt or not as a
second-generation substitute is, as discussed above, what it is designed
to replace.  For example, SNAP reviews are not meant to cover cases in
which a technology is designed for use primarily in replacing existing
non-ozone depleting evaporative cooling systems.  In general, if most
intended uses for a possible substitute are to replace a non-OD
substitute for a class I or class II substance, then this substance
would therefore be a second-generation substitute, and SNAP review is
unlikely to be required.  In those situations where class I or class II
substitutes have already been replaced in most applications, the small
use exemption could also eliminate the need for review of next
generation substitutes.

			g.	Applicability to Existing Uses  59 FR 13052

	The prohibition on use of an alternative applies only to substitutions
to unacceptable substitutes made after the effective date of any final
rulemaking for unacceptability.  However, for this final rule, any
person who has transitioned to a substitute for an end-use prior to any
SNAP final rulemaking designating it as unacceptable may continue to use
the substitute until their existing supply of the chemical, as of
[insert date of publication], is depleted.

	Existing inventory of final products manufactured with or containing a
substitute designated unacceptable as a result of final EPA rule-making
within an end-use covered under SNAP could theoretically be legally sold
after listing.  Producers should be aware, however, that they will be
effectively barred from selling a substitute for use once it has been
deemed unacceptable under SNAP, because potential purchasers will not be
able to use it.  After the effective date of this final rule, users will
not be able to use any additional supply of a banned substitute
purchased after the publication date of the unacceptable listing.


[Federal Register: July 16, 2009 (Volume 74, Number 135)]
[Notices]
[Page 34563-34564]
[DOCID:fr16jy09-35]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13486-000]

FFP Project 76, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

July 9, 2009.
    On May 22, 2009, FFP Project 76, LLC filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Burke Landing Hydrokinetic
Project, to be located on the Mississippi River, in Phillips County,
Arkansas and Coahoma County, Mississippi.
    The sole purpose of a preliminary permit, if issued, is to grant
the permit holder priority to file a license application during the
permit term. A preliminary permit does not authorize the permit holder
to perform any land disturbing activities or otherwise enter upon lands
or waters owned by others without the owners' express permission.
    The proposed Burke Landing Hydrokinetic Project consists of: (1)
2,028 proposed 40 kilowatt Free Flow generating units having a total
installed capacity of 81.12 megawatts; (2) a 2.2-mile-long, 69 kilovolt
transmission line; and (3) appurtenant facilities. The proposed Burke
Landing Hydrokinetic Project would have an average annual generation of
355 gigawatt-hours.
    Applicant Contact: Ramya Swaminathan, Vice President of
Development, Free Flow Power Corporation, 33 Commercial Street,
Gloucester, MA 01930; phone:<PHONE_NUMBER>.
    FERC Contact: Kim Carter,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the

Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project, including a copy of
the application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13486) in the docket number field to access
the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16851 Filed 7-15-09; 8:45 am]

BILLING CODE 6717-01-P


 P-21-0186-0187 Sanitized Support Documents Index:
 P-21-0186 Sanitized Premanufacture Notice (linked)
 P-21-0187 Sanitized Premanufacture Notice (linked)
 P-21-0186-0187 Sanitized Determination Document (linked)
 P-21-0186 Sanitized CHEM Report (attached)
 P-21-0186 Sanitized ECO Report (attached)
 P-21-0186 Sanitized EXP Report (attached)
 P-21-0186 Sanitized Fate Report (attached)
 P-21-0187 Sanitized CHEM Report (attached)
 P-21-0187 Sanitized ECO Report (attached)
 P-21-0187 Sanitized EXP Report (attached)
 P-21-0187 Sanitized Fate Report (attached)
 P-21-0186-0187 Sanitized ENG Report (attached)
 P-21-0186-0187 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


DEPARTMENT OF THE TREASURY ALCOHOL AND TOBACCO TAX AND TRADE BUREAU ( TTB)

ENVIRONMENTAL INFORMATION 1. Name and Principal Business Address of Applicant 2. Description of Activity in which Alcohol and Tobacco Tax and Trade Bureau has an interest 3. Number of Employees 4. Location Where Activity is to be Conducted ( Be specific, Number, Street, City, State, ZIP Code; describe locations of buildings and outside equipment and their situation relative to surrounding environment including other structutres, land use, lakes, streams, roads, railroad facilities, etc. Maps, photos, or drawings may be provided.)

5. Heat and Power: A. Describe types of heat and power to be used and their sources. If they are to be produced in connection with the proposed activity, estimate type and quantity of fuel to be used for each purpose. ( Example: 40 tons/ yr. anthracite coal for heat, 20 million cu. ft./ yr. natural for power generating.)

B. Describe any air pollution control equipment proposed for use in connection with fuel burning equipment, boilers, or smokestacks.

6. Solid Waste: A. Describe amount and composition of all solid waste to be generated.

B. Discuss proposed methods of disposal ( Incineration, open burning, landfill, government or commercial garbage collection, etc.) Specify whether on site or off site.

C. Describe any air pollution control equipment proposed for use in connection with any incinerators.

TTB F 5000.29 ( 4/ 2004) OMB No. 1513 0023 ( 06/ 30/ 2005)

1. COMPLETION. Answer all items in sufficient detail or as not applicable to your activity. The information on all items should relate to the activity in which the Bureau has an interest. If additional space is required for any item, please attach a separate sheet identified by the item number of this form. Your answers are evaluated by the Bureau to determine whether the activity will have a significant effect on the environment. If TTB F 5000.30, Supplemental Information on Water Quality Considerations  Under 33 U. S. C. 1341( a), is also being submitted for your activity, you may make reference to any relevant information given on TTB F 5000.30 for items 6 and 7 of this form.

2. FILING. Submit an original and one copy of this form to the Director, National Revenue Center, 550 Main Street, Suite 8002, Cincinnati, OH 45202.

3. DISPOSITION. After final action taken on the related application or other document, the copy of this form will be returned to the applicant. INSTRUCTIONS 7. Liquid Waste ( Complete this item irrespective of any certification obtained as to compliance with any environmental quality standards of any Federal, State, or local agency having responsibilty for environmental protection including any certification under the Federal Water Pollution Control Act.) A. Describe amount and content of any liquid waste to be generated.

B. Describe proposed method of disposal ( Sewer, flaming, recycling, etc). Describe any proposed means to monitor quality and characteristics, and any proposed equipment or facilities for treatment or control of liquid wastes.

8. Noise ( Describe operational noise sources other than those normally associated with office operations, building maintenance, or utilities.)

UNDER PENALTIES OF PERJURY, I DECLARE THAT I HAVE EXAMINED THE INFORMATION SHOWN ON THIS FORM AND, TO THE BEST OF MY KNOWLEDGE AND BELIEF, IT IS TRUE, CORRECT, AND COMPLETE. I AGREE THAT COPIES OF THIS FORM MAY BE FURNISHED TO CONCERNED FEDERAL, STATE, AND LOCAL AGENCIES HAVING RESPONSIBILITIES FOR ENVIRONMENTAL PROTECTION AND THAT THE INFORMATION HEREON MAY BE USED IN THE PREPARATION OF AN ENVIRONMENTAL STATEMENT PURSUANT TO THE REQUIREMENTS OF THE NATIONAL ENVIRONMENTAL POLICY ACT, 42 U. S. C. 4332.

9. Date 10. Applicant 11. By ( Signature and Title)

Alcohol and Tobacco Tax and Trade Bureau Determination of Effect. After consideration of all available environmental information relevant to the proposed activity, it is determined that:

The conduct of the activity described in item 2, pursuant to issuance or approval of the ( Specify whether application, bond, formula, permit, license, etc.)

will will not significantly affect the environment.

Signature of Director, National Revenue Center Date TTB F 5000.29 ( 4/ 2004) PAPERWORK REDUCTION ACT NOTICE This request is in accordance with Section 3507, Public Law 96 511, Paperwork Reduction Act of 1995. This information collection is used by TTB to determine if any environmental impact statement or environmental permit is necessary for the proposed operation. The information is required to obtain a benefit.

The estimated average burden associated with this collection of information is 30 minutes per respondent or recordkeeper, depending on individual circumstances Comments concerning the accuracy of this burden estimate and suggestions for reducing this burden should be addressed to Reports Management Officer, Regulations and Procedures Division, Alcohol and Tobacco Tax and Trade Bureau, Washington, DC 20220.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.


[Federal Register: September 22, 2009 (Volume 74, Number 182)]
[Notices]
[Page 48343-48345]
[DOCID:fr22se09-147]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket ID. FMCSA-2009-0154]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 40 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). The exemptions will enable these individuals to operate
commercial motor vehicles (CMVs) in interstate commerce without meeting
the prescribed vision standard. The Agency has concluded that granting
these exemptions will provide a level of safety that is equivalent to,
or greater than, the level of safety maintained without the exemptions
for these CMV drivers.

DATES: The exemptions are effective September 22, 2009. The exemptions
expire on September 22, 2011.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments online.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://Docketsinfo.dot.gov.

Background

    On July 28, 2009, FMCSA published a notice of receipt of exemption
applications from certain individuals, and requested comments from the
public (74 FR 37295). That notice listed 40 applicants' case histories.
The 40 individuals applied for exemptions from the vision requirement
in 49 CFR 391.41(b)(10), for drivers who operate CMVs in interstate
commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to, or greater than, the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 40 applications on their merits
and made a determination to grant exemptions to all of them.

Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of at least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing standard
red, green, and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision standard,
but have adapted their driving to accommodate their vision limitation
and demonstrated their ability to drive safely.
    The 40 exemption applicants listed in this notice are in this
category. They are unable to meet the vision standard in one eye for
various reasons, including amblyopia, optic nerve defect, retinal vein
occlusion, pappilodema, optic atrophy, prosthesis, retinal detachment,
retinal scarring, macular scarring, and loss of vision due to trauma.
In most cases, their eye conditions were not recently developed. All
but 16 of the applicants were either born with their vision impairments
or have had them since childhood. The 16 individuals who sustained
their vision conditions as adults have had them for periods ranging
from 4 to 36 years.
    Although each applicant has one eye which does not meet the vision
standard in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All these applicants satisfied the testing standards for their
State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a commercial vehicle,
with their limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 40 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision for careers ranging from 4 to 49
years. In the past 3 years, eight of the drivers had convictions for
traffic violations and two of the drivers were involved in crashes.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in the July 28, 2009
notice (74 FR 37295).

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision standard in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered not only the medical reports about the applicants' vision,
but also

their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision standard, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at docket number FMCSA-1998-3637.
    We believe we can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 40 applicants, seven of the applicants had traffic violations for
speeding, one of the applicants had traffic violation for failure to
obey a traffic sign, and two of the applicants were involved in
crashes. The applicants achieved this record of safety while driving
with their vision impairment, demonstrating the likelihood that they
have adapted their driving skills to accommodate their condition. As
the applicants' ample driving histories with their vision deficiencies
are good predictors of future performance, FMCSA concludes their
ability to drive safely can be projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision standard in
49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 40 applicants listed in the notice of July
28, 2009 (74 FR 37295).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 40 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the standard in 49 CFR 391.41(b)(10),
and (b) by a medical examiner who attests that the individual is
otherwise physically qualified under 49 CFR 391.41; (2) that each
individual provide a copy of the ophthalmologist's or optometrist's
report to the medical examiner at the time of the annual medical
examination; and (3) that each individual provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the certification when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

Discussion of Comments

    FMCSA received two comments in this proceeding. The comments were
considered and discussed below.
    The Pennsylvania Department of Transportation expressed that it had
reviewed the driving records for Marvin Leroy Stein and was in favor of
granting the Federal vision exemptions to him.
    The second comment was anonymous and was submitted in favor of
granting the Federal vision exemption to Mark Anderson.

Conclusion

    Based upon its evaluation of the 40 exemption applications, FMCSA
exempts, Michael K. Adams, Michael J. Amorese, Mark R. Anderson,
Darrell W. Bayless, Keith A. Bliss, Lloyd D. Burgess, Gary R. Butler,
David S. Clinger, Ronald L. Cote, John C. Defoe, Shennon E. Dorsey,
Steve E. Duran, Michael M. Edleston, Cecil A. Evey, Kamal A. Gaddah,
Bradley O. Hart, John M. Homchick, Terry L. Hudgens, Eric M. Kousgaard,
Larry L. Massey, Joe A. McIntyre, James F. McMahon, Jr., Samuel A.
Miller, Marvin L. Motes, John W. Myre, Noah I. Pennington, Ronald D.
Peters, Stephen Pozharsky, Angelo D. Rogers, Larry T. Rogers, Ricky J.
Sanderson, George V. Sorondo, Marcial Soto-Rivas, Marvin L. Stein,
David C. Sybesma, Bruce E. Thulin, Matthew K. Tucker, Stanley W. Tyler,
Jr., Victor H. Vera, and Charles A. Winchell from the vision
requirement in 49 CFR 391.41(b)(10), subject to the requirements cited
above (49 CFR 391.64(b)).
    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid

for 2 years unless revoked earlier by FMCSA. The exemption will be
revoked if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E9-22768 Filed 9-21-09; 8:45 am]

BILLING CODE 4910-EX-P


[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84348-84349]
[FR Doc No: 2020-28560]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4303]

Providing Regulatory Submissions in Electronic Format--Content of
the Risk Evaluation and Mitigation Strategies Document Using Structured
Product Labeling; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Providing
Regulatory Submissions in Electronic Format--Content of the Risk
Evaluation and Mitigation Strategies Document Using Structured Product
Labeling.'' This guidance is being issued in accordance with the Food
and Drug Administration Safety and Innovation Act (FDASIA), which
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require
that certain submissions under the FD&C Act and the Public Health
Service Act (PHS Act) be submitted in electronic format, beginning no
earlier than 24 months after issuance of final guidance on electronic
format for submissions. The guidance describes how FDA plans to
implement the requirements for the electronic submission of Risk
Evaluation and Mitigation Strategies (REMS) documents in certain
submissions under new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and certain biologics license applications
(BLAs), beginning December 28, 2022. This guidance finalizes the draft
guidance entitled ``Providing Regulatory Submissions in Electronic
Format--Content of the Risk Evaluation and Mitigation Strategies
Document Using Structured Product Labeling'' published September 5,
2017.

DATES: The announcement of the guidance is published in the Federal
Register on December 28, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-4303 for ``Providing Regulatory Submissions in Electronic
Format--Content of the Risk Evaluation and Mitigation Strategies
Document Using Structured Product Labeling.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).

    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Nancy Guan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen Ripley, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using
Structured Product Labeling.'' FDASIA amended the FD&C Act to require
that certain submissions under the FD&C Act and the PHS Act be
submitted in electronic format, beginning no earlier than 24 months
after issuance of final guidance on electronic format for submissions.
This guidance describes how FDA plans to implement the requirements for
the electronic submission of REMS documents in certain submissions
under NDAs, ANDAs, and certain BLAs, beginning December 28, 2022.
    This guidance finalizes the draft guidance entitled ``Providing
Regulatory Submissions in Electronic Format--Content of the Risk
Evaluation and Mitigation Strategies Document Using Structured Product
Labeling'' issued September 5, 2017 (82 FR 41968). FDA has considered
all the public comments received on the draft guidance in finalizing
this guidance. FDA made editorial changes to improve clarity and
address comments as appropriate. FDA also amended language in Part
III.C of the guidance to reflect the recent publication of exemption
and waiver criteria for eCTD submissions in a separate guidance.
    FDA guidances ordinarily contain standard language explaining that
guidances should be viewed only as recommendations unless specific
regulatory or statutory requirements are cited. FDA is not including
this standard language in this guidance because this guidance contains
binding provisions. In section 745A(a) of the FD&C Act, Congress
granted explicit authorization to FDA to specify in guidance the format
for the electronic submissions required under that section.
Accordingly, this guidance explains such requirements under section
745A(a) of the FD&C Act, indicated by the use of the words must or
required, and therefore is not subject to the usual restrictions in
FDA's good guidance practice regulations, such as the requirement that
guidances not establish legally enforceable responsibilities. See 21
CFR 10.115(d). This guidance represents the Agency's current thinking
on ``Providing Regulatory Submissions in Electronic Format--Content of
the Risk Evaluation and Mitigation Strategies Document Using Structured
Product Labeling.''

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 314 have been approved under OMB control
number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 21, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28560 Filed 12-23-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 132 (Tuesday, July 10, 2012)]
[Notices]
[Pages 40671-40673]
[FR Doc No: 2012-16768]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-67346; File No. SR-NYSEMKT-2012-15]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Certain
Exchange Rules Related to Floor Official Duties and Responsibilities in
the Exchange's Marketplace

July 3, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on June 21, 2012, NYSE MKT LLC (``NYSE MKT'' or ``Exchange'')
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 the self-regulatory organization. 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.
---------------------------------------------------------------------------

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

    The Exchange proposes to amend certain Exchange Rules related to
Floor Official duties and responsibilities in the Exchange's
marketplace. The text of the proposed rule change is available on the
Exchange's Web site at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to amend certain Exchange Rules pertaining to
the

duties and responsibilities of Floor Officials in the Exchange
marketplace.
    The role of the Floor Official evolved out of the self-regulatory
scheme of the Securities Exchange Act of 1934, as amended (the
``Act'').\3\ A number of Exchange Rules specify involvement in the
marketplace by Floor Officials, senior-level Floor Officials (i.e.,
Floor Governors, Executive Floor Officials, Senior Floor Officials and
Executive Floor Governors), or both.\4\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78f.
    \4\ See NYSE MKT Rules 46--Equities and 46A--Equities (defining
Floor Official, Floor Governor, Executive Floor Official, Senior
Floor Official and Executive Floor Governors).
---------------------------------------------------------------------------

    Typically, the Floor Official's role on the Floor of the Exchange
involves the consideration of requests to execute a particular kind of
transaction or the supervision of specified trading situations. In
addition to their formal role prescribed by the Exchange rules, Floor
Officials also provide a more general level of oversight to the
marketplace on a day-to-day basis.
    Given the evolution of the equities markets away from manual
executions and manual enforcement of rules toward an electronic market
that automates executions and in many cases hard codes the rule
requirements into the execution logic, many of the trading procedures
and situations originally requiring Floor Officials involvement have
been automated; in other cases, the Floor Official approval has become
pro forma rather than substantive. In light of this, the Exchange
determined that several Exchange Rules should be amended with respect
to the duties and responsibilities once assigned to Floor Officials to
better comport with today's Exchange market structure.
Proposed Amendments
    NYSE MKT Rule 122--Equities provides that, to avoid unfair
allocation of securities traded, no member or member organization shall
maintain with more than one broker on the Exchange market orders or
orders at the same price for the purchase or sale of the same security
for the account of the same principal unless permission has been
obtained from a Floor Official. The Exchange proposes to amend the rule
to remove this approval as a Floor Official function and therefore ban
this practice outright.
    The Exchange also proposes amending NYSE MKT Rule 128B--Equities,
which prescribes the procedures for the publication of changes,
cancellations or other errors on the consolidated tape (the ``Tape'').
Specifically, Rule 128B.10--Equities requires Floor Official approval
to change or correct a transaction that previously appeared on the
Tape, cancel a transaction that previously appeared on the Tape and
that has been agreed to by all buyers and sellers, and publish a
transaction omitted from the Tape (i.e., a sold or sold last sale). In
addition, Rule 128B.13--Equities requires Floor Official approval for
the publication of a correction to a transaction erroneously reported
to ``a reporter'' by a party to the transaction. In the interests of
maintaining the integrity of the Tape, the Exchange proposes to elevate
the level of approval required under Rules 128B.10--Equities and .13--
Equities from Floor Official to senior-level Floor Official (i.e.,
Floor Governors, Executive Floor Officials, Senior Floor Officials and
Executive Floor Governors). In addition, the Exchange proposes to
delete ``to a reporter'' in NYSE MKT Rule 128B.13--Equities.
Historically, Floor reporters were Exchange employees responsible for
collecting and inputting transaction data into the ticker system. The
position was eliminated many years ago.
    Finally, NYSE MKT Rule 128B.10--Equities provides that, in addition
to (proposed senior-level) Floor Official approval, both ``buying and
selling members'' must agree to the publication of (1) A change or a
correction in a transaction that previously appeared on the Tape, (2)
the cancellation of a transaction which previously appeared on the Tape
and which was properly rescinded, or (3) a transaction omitted from the
Tape made on the Tape on the day of the transaction. The Exchange
proposes to add ``or member organizations'' after ``buying and selling
members.'' NYSE MKT Rule 2--Equities defines a ``member'' as a natural
person. A significant number of Exchange member organizations, however,
no longer have Floor-based members, and nearly all transactions printed
to the Tape are executed by automated systems. The proposed change to
NYSE MKT Rule 128B.10--Equities reflects the changes in the NYSE MKT
marketplace away from Floor-based members manually executing the
majority of trades printed to the Tape to more automated trading by an
increasing number of non-Floor based member organizations.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and Section
6(b)(4) of the Act,\6\ in particular, in that it is designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities, and to
remove impediments to and perfect the mechanism of a free and open
market and a national market system. Specifically, the Exchange
believes that the proposed rule changes support the objectives of the
Act by amending and/or delegating duties and responsibilities once
assigned to Floor Officials to better comport with the Exchange's
current market structure and to reflect rapidly changing market
technology and the development of automated systems.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f(b).
    \6\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

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

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed the proposed rule change
has become effective pursuant to Section 19(b)(3)(A) of the Act and
Rule 19b-4(f)(6)(iii) thereunder.\9\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
    \9\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal will assist the

Exchange in maintaining a fair and orderly market by allowing market
participants who agree to cancel a transaction to do so more
efficiently, thereby potentially reducing the likelihood that
transactions will be printed to the Tape incorrectly. Therefore, the
Commission designates the proposal operative upon filing.\10\
---------------------------------------------------------------------------

    \10\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rules impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2012-15 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEMKT-2012-15. This
file number should be included on the subject line if email 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-NYSEMKT-2012-15 and should
be submitted on or before July 31, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-16768 Filed 7-9-12; 8:45 am]
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[Federal Register: June 8, 2010 (Volume 75, Number 109)]
[Notices]
[Page 32535]
[DOCID:fr08jn10-166]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Office of the Secretary

Applications for Certificates of Public Convenience and Necessity
and Foreign Air Carrier Permits Under Subpart B; Week Ending May 22,
2010

    Notice of Applications for Certificates of Public Convenience and
Necessity and Foreign Air Carrier Permits Filed Under subpart B
(formerly subpart Q) during the Week Ending May 22, 2010. The following
Applications for Certificates of Public Convenience and Necessity and
Foreign Air Carrier Permits were filed under subpart B (formerly
subpart Q) of the Department of Transportation's Procedural Regulations
(See 14 CFR 301.201 et seq.). The due date for Answers, Conforming
Applications, or Motions to Modify Scope are set forth below for each
application. Following the Answer period DOT may process the
application by expedited procedures. Such procedures may consist of the
adoption of a show-cause order, a tentative order, or in appropriate
cases a final order without further proceedings.
    Docket Number: DOT-OST-2010-0126.
    Date Filed: May 18, 2010.
    Due Date for Answers, Conforming Applications, or Motion To Modify
Scope: June 8, 2010.
    Description: Application of Carlsbad-Palomar Airlines, Inc.
requesting a certificate of public convenience and necessity to engage
in scheduled interstate air transportation of persons, property and
cargo.

 Renee V. Wright,
Program Manager, Docket Operations, Federal Register Liaison.
[FR Doc. 2010-13656 Filed 6-7-10; 8:45 am]
BILLING CODE 4910-9X-P


From:
David Ailor<EMAIL_ADDRESS>Sent:
Friday, March 5, 2021 7:18 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Cc:
Raymond, Gabrielle<EMAIL_ADDRESS>Subject:
RE: coke model files have gone to EPA division QA

Hello again, Donna Lee.  Hope you're well.

Thanks again for the compiled modeling files you sent us on March 1.  The consultants who are assisting the Coke Oven Environmental Task Force (COETF) in the RTR effort, Montrose and AECOM, have started reviewing the populated emissions files.  They have identified several questions/issues that we wanted to call to your attention right away, so EPA does not get too far along in its QA review without correcting them.

Below is a list of questions/issues identified so far (we may have others as we continue our review):

PQBS category source file
 Industry average emissions factors vs. ICR test data at the same facilities  -  The emissions spreadsheet uses industry average emissions factors for all emission units that were not ICR tested, even when the same type of emission unit was tested at the same facility.  For example, for Burns Harbor baghouse #2 (which was tested), the spreadsheet uses the ICR test data-derived emission factors, but for baghouse #1 (which was not tested) the spreadsheet uses industry average emissions factors.  When ICR test data are available for a facility, we believe those data should be used for all similar emission units at the facility because ICR test data best reflect the particular type of coal, the same coking time and other operating practices, etc. and, so, is more representative than industry average emission factors.  We ask EPA to correct the spreadsheet to use the ICR test-derived emissions factors for all similar emission units at ICR tested facilities.

 Allowable emission rates  -  In many instances the allowable emission rates are orders of magnitude higher than the expected values based on maximum production levels.  It is unclear how EPA derived these values and some of the resulting emission rates are wholly implausible.  The allowable emission rate for each emission unit should be derived (as EPA did in the Taconite RTR, for example) by multiplying the actual emission rate of the emission unit by the ratio of the maximum production rate for the facility to the actual production rate for that facility in a representative year.  The COETF discussed this issue with EPA previously and provided the actual and maximum production rates for all COETF member facilities (see Table 1 below).  We ask that EPA use the actual-to-allowable ratios in Table 1 to calculate the allowable emission rates for each facility.

 Fugitive pushing emissions  -  The fugitive pushing emissions for gaseous pollutants are up to orders of magnitude higher than the correct values.  We believe this problem stems from the use of PM speciation factors for gaseous pollutants in the Coke_Fugitive_Emissions spreadsheet.  The PM speciation factor approach we recommended is applicable only to particulate pollutants, such as the HAP metals and semi-volatiles that were tested at the ABC Coke and Burns Harbor baghouse inlets by EPA in 1998.  Fugitive pushing emissions for gaseous pollutants, including the volatile HAPs and acid gases (HCl, HF, and HCN), should be calculated using the appropriate PQBS ICR industry test data-derived emission factor times the annual coke production, adjusted for the capture efficiency.  These emission factors, taken from the most recent (2/15/2021) Whole Industry Test Data Spreadsheet (Tab A-3. Industry Default EFactors), are listed in Table 2 below.

      For example, the HCl pushing emission factor for foundry coke plants is 1.00E-03 lb/ton coke.  For ABC Coke Battery No. 1, which produced 377,606 tons of coke in 2015, the total HCl emission from pushing would be:

      (1.00E-03 lb/ton coke)(377,606 tons coke/year)/(2000 lb/ton) = 0.189 ton/year

      Accounting for the pushing capture efficiency of 95.02%, the fugitive HCl emissions would be:

                  (0.189 tons/year)(1  -  0.9502) = 0.009 ton/year

      The Category Source file lists ABC Coke actual fugitive HCl emissions for Battery No. 1 at 6.68 tons/year, a factor of about 700 higher.  We ask that EPA correct these values using the appropriate ICR test data emission factors.

 Pushing baghouse emissions (ABC Coke)  -  The pushing baghouse emissions factors at ABC Coke are also significantly overstated.  It's unclear how the spreadsheet values were derived, so we ask EPA to provide the calculations, including the emissions factor that was used, so we can respond more fully.

 Production rates (ABC Coke)  -  The spreadsheet applies the coke production rate for Battery 1 to the North tower and the coke production rate for Battery 5-6 to the South tower.  These should be reversed.

Non-category source file
 Allowable emission rates  -  As with the source category file, the allowable emission rates for non-category sources are orders of magnitude higher than the expected values.  We ask that the actual-to-allowable ratios in Table 1 below be used to calculate the allowable emission rates for non-category sources.

 Acute emissions multiplier  -  The spreadsheet uses an annual-to-hourly emissions multiplier of 2.0 for all sources except flares, which has a multiplier of 10.  Why did EPA not use the same 2.0 multiplier?

 Inconsistent source heights  -

          Cells AP4, 5, 7, 8, 10, 11, 13, 14, 16, 17 for ABC Coke have inconsistent battery heights in comparison to AP3, 6, 9, 12, and 15.  Please revise.

          Cells AP100-102, 104-106, 108-110, 112-114, 116-118 for AKS-Follansbee (Mountain State Carbon) have inconsistent battery heights in comparison to AP104, 107, 111, 115.  Please revise.

            *           *           *           *           *           *           *           *           *           *           *           *            *           *           *           *           *           *           *           *           *           *           *           *

We greatly appreciate your efforts addressing these questions/issues and look forward to EPA's responses.  Given the time sensitivity of EPA's QA review, the COETF can provide the corrected emissions files if doing so would be helpful and if EPA indicates that it will use the corrected files.  Please let us know.
Thanks, DCA

                        *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           *           * *

Table 1:  Ratios of Actual-to-Potential Coal Charge to be Used for Estimating Potential Emissions from Actual Emissions

Table 2:  Pushing Emission Factors to be Used in the Calculation of Fugitive Pushing Emissions for Gaseous Pollutants

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

From: David Ailor<EMAIL_ADDRESS>Sent: Monday, March 1, 2021 1:07 PM
To: 'Jones, DonnaLee'<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc: 'GABRIELLE RAYMOND'<EMAIL_ADDRESS>Subject: RE: coke model files have gone to EPA division QA

Agreed!  Thanks, Donna Lee.  DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Monday, March 1, 2021 12:46 PM
To: David Ailor<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Cc: GABRIELLE RAYMOND<EMAIL_ADDRESS>Subject: coke model files have gone to EPA division QA

Hello David and Katie. Here are the compiled modeling files that I sent to my division for QA. It may take a couple of weeks (or more) for this review. We use an outside contractor to check these files, mostly for proper coding and mathematical inconsistencies.  At that point, if no errors or after errors are corrected, the files go on to the risk modelers who check for consistencies in modeling parameters and locations. At that point, if no errors or after correction of errors, we will post the files to the public NESHAP website while the risk modeling is being done. I will keep you both posted on all steps in the process.

Thanks to you and your staff and collaborators for the help working with us to get the data in best condition possible. It's been a long, sometimes hard journey to this point, so we should all congratulate ourselves!

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.


[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Notices]
[Pages 35451-35452]
[FR Doc No: 2011-15019]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Oncologic Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 14, 2011, from 8
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993-0002. Information regarding special accommodations due to a
disability, visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
    Contact Person: Caleb Briggs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX: 301-847-
8533, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), and
follow the prompts to the desired center or product area. Please call
the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
    Agenda: On July 14, 2011, during the morning session, the committee
will discuss biologics license application (BLA) 125388, with the
proposed trade name ADCETRIS (brentuximab vedotin) for injection,
submitted by Seattle Genetics, Inc. The proposed indication (use) for
this product is for the treatment of relapsed or refractory (resistant
to previous standard treatments) Hodgkin's lymphoma.
    During the afternoon session, the committee will discuss BLA
125399, with the proposed trade name ADCETRIS (brentuximab vedotin) for
injection, submitted by Seattle Genetics, Inc. The proposed indication
(use) for this product is for the treatment of relapsed or refractory
systemic anaplastic large cell lymphoma.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background

material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before July
6, 2011. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before June
29, 2011. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by June 30, 2011.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Caleb Briggs at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: June 9, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-15019 Filed 6-16-11; 8:45 am]
BILLING CODE 4160-01-P