[Federal Register Volume 84, Number 71 (Friday, April 12, 2019)]
[Rules and Regulations]
[Pages 14881-14883]
[FR Doc No: 2019-07334]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R05-OAR-2018-0572; FRL-9992-21-Region 5]

Air Plan Approval; Ohio; Redesignation of the Cleveland Area to
Attainment of the 2012 Annual Standard for Fine Particulate Matter

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving the
Ohio Environmental Protection Agency's (Ohio) request to redesignate
the Cleveland area to attainment of the 2012 annual national ambient
air quality standard (NAAQS or standards) for fine particulate matter
(PM2.5) under the Clean Air Act (CAA).

DATES: This final rule is effective on April 12, 2019.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2018-0572. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. We recommend
that you telephone Michael Leslie, Environmental Engineer, at (312)
353-6680 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Michael Leslie, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is being addressed by this document?
II. What comments did we receive on the proposed SIP revision?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is being addressed by this document?

    On July 24, 2018, Ohio submitted a request for EPA to redesignate
the Cleveland area to attainment of the 2012 annual PM2.5
NAAQS under section 107(d)(3)(E) the CAA. On December 26, 2018, at 83
FR 66200, EPA proposed to approve the State's revision to the SIP for
the 2012 PM2.5 NAAQS in the Cleveland nonattainment area.

II. What comments did we receive on the proposed SIP revision?

    Our December 26, 2018 proposed rule provided a 30-day review and
comment period. The comment period closed on January 25, 2019. EPA
received no comments during the public comment period.

III. What action is EPA taking?

    EPA is approving a change to the official designation of the
Cleveland, Ohio area for the 2012 annual PM2.5 NAAQS, found
at 40 CFR part 81, from nonattainment to attainment. EPA is approving a
determination that the Cleveland area has attained the 2012 annual
PM2.5 standard, based on the most recent three years of
certified air quality data. This action also approves the maintenance
plan for the 2012 annual PM2.5 NAAQS as revision to the Ohio
SIP for the Cleveland area. Finally, EPA is approving 2022 and 2030
primary PM2.5 and nitrogen oxide motor vehicle emission
budgets (MVEBs) for the Cleveland area. These MVEBs will be used in
future transportation conformity analyses for the area.
    In accordance with 5 U.S.C. 553(d), EPA finds there is good cause
for these actions to become effective immediately upon publication.
This is because a delayed effective date is unnecessary due to the
nature of a redesignation to attainment, which relieves the area from
certain CAA requirements that would otherwise apply to it. The
immediate effective date for this action is authorized under both 5
U.S.C. 553(d)(1), which provides that rulemaking actions may become
effective less than 30 days after publication if the rule ``grants or
recognizes an exemption or relieves a restriction,'' and section
553(d)(3), which allows an effective date less than 30 days after
publication ``as otherwise provided by the agency for good cause found
and published with the rule.'' The purpose of the 30-day waiting period
prescribed in section 553(d) is to give affected parties a reasonable
time to adjust their behavior and prepare before the final rule takes
effect. This rule, however, does not create any new regulatory
requirements such that affected parties would need time to prepare
before the rule takes effect. Rather, this rule relieves the state of
planning requirements for this PM2.5 nonattainment area. For
these reasons, EPA finds good cause under 5 U.S.C. 553(d)(3) for these
actions to become effective on the date of publication of these
actions.

IV. Statutory and Executive Order Reviews

    Under the CAA, redesignation of an area to attainment and the
accompanying approval of the maintenance plan under CAA section
107(d)(3)(E) are actions that affect the status of geographical area
and do not impose any additional regulatory requirements on sources
beyond those required by state law. A redesignation to attainment does
not in and of itself impose any new requirements, but rather results in
the application of requirements contained in the CAA for areas that
have been redesignated to attainment. Moreover, the Administrator is
required to approve a SIP submission that complies with the provisions
of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40
CFR 52.02(a). Thus, in reviewing SIP submissions,

EPA's role is to approve state choices, provided that they meet the
criteria of the CAA. Accordingly, this action merely approves state law
as meeting Federal requirements and does not impose additional
requirements beyond those imposed by state law. For that reason, this
action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 11, 2019. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen dioxide, Particulate
matter, Sulfur oxides, Volatile organic compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: March 25, 2019.
Cathy Stepp,
Regional Administrator, Region 5.

    Title 40 CFR parts 52 and 81 are amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1870, the table in paragraph (e) is amended under
``Summary of Criteria Pollutant Maintenance Plan'' by adding an entry
``PM2.5 (2012)'' before the entry ``SO2 (1971)''
(with a State date of 6/25/1992) to read as follows:

Sec.  52.1870  Identification of plan.

* * * * *
    (e) * * *

                         EPA-Approved Ohio Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                  Applicable
           Title             geographical or non-    State date        EPA approval             Comments
                                attainment area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Summary of Criteria Pollutant Maintenance Plan
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
PM2.5 (2012)...............  Cleveland...........       7/24/2018  4/12/2019, [insert   EPA is approving the
                                                                    Federal Register     following elements: a
                                                                    citation].           determination that the
                                                                                Cleveland area has
                                                                                attained the 2012
                                                                                annual PM2.5 standard,
                                                                                a maintenance plan for
                                                                                the 2012 annual PM2.5
                                                                                NAAQS, 2022 and 2030
                                                                                primary PM2.5 and NOX
                                                                                MVEBs for the Cleveland
                                                                                area.

                                                  * * * * * * *
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PART 81--DESIGNATION OF AREAS FOR AIR QUALITY PLANNING PURPOSES

0
3. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7401, et seq.

0
4. Section 81.336 is amended by revising the entry ``Cleveland, OH'' in
the table entitled ``Ohio--2012 Annual PM2.5 NAAQS'' to read
as follows:

Sec.  81.336  Ohio.

* * * * *

                                          Ohio--2012 Annual PM2.5 NAAQS
                                                    [Primary]
----------------------------------------------------------------------------------------------------------------
                                                 Designation                           Classification
        Designated area \1\        -----------------------------------------------------------------------------
                                       Date \2\              Type             Date \2\              Type
----------------------------------------------------------------------------------------------------------------
Cleveland, OH:
    Cuyahoga County...............       4/12/2019  Attainment                             Moderate
    Lorain County.................       4/12/2019  Attainment                             Moderate

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Includes areas of Indian country located in each county or area, except as otherwise specified.
\2\ This date is April 15, 2015, unless otherwise noted.

* * * * *
[FR Doc. 2019-07334 Filed 4-11-19; 8:45 am]
BILLING CODE 6560-50-P


MEMORANDUM

April 18, 2007

To: Dave Salman

From: Gary Jones, Marci Kinter, Doreen Monteleone

Re: Response to Questions Regarding Proposed PFFC CTG Exclusion for
Printing

Please see the responses below to the questions that were raised
regarding the proposed Paper, Film, Foil Coating Control Techniques
Guideline exclusion for printing operations. Each response to the
question has been bolded for easier reference.

I don't have the current draft paper, film and foil CTG for context, but
I think the general direction of this makes sense.  There is "coating"
done on "presses".  When these "presses" or the application of these
"coatings" is within the scope of another CTG (for example, 2006
flexible packaging CTG, 2006 offset lithography and letterpress, 1978
graphic arts CTG) it makes sense for us to say (recommend) that it is
not within the scope of the new paper, film and foil CTG.  The same may
be true in some cases where we don't have a CTG (for example, screen
printing and digital printing).

I have the following comments and questions about the suggested
language:

For purposes of this CTG, any offset lithographic, screen, letterpress,
flexographic, rotogravure, or digital printing and (1) packaging (2)
line including any in-line and (3) auxiliary coating, (4) laminating,
and adhesive application is not subject to the recommendations in this
CTG. (5) Inks, adhesives, and other coating materials used in (6) these
operations are also not subject to the recommended limits of this CTG.

(1)  I don't understand why the word "packaging" is here.  What does it
add that is not already taken care of by listing the various types of
printing?  If it belongs here, why is it "packaging" rather than
"flexible packaging"?

ANSWER:  We included the word packaging to ensure that the definition
includes traditional printing operations as well as packaging operations
that involve printing, such as flexible packaging or other types of
converting, such as folding carton packaging.  If print processes are
considered all-inclusive and not tied to a specific product, then this
term may not be necessary.

(2) Why "line"?  Why not "press"?

ANSWER:  To the industry, “line” is more inclusive of all activities
associated with the actual production of a product, and includes not
only the printing press but also associated work stations where coating,
adhesive application, laminating, etc., are performed.  Since these work
stations are not “printing” operations, they are not technically
part of a press.  The term “line” has been included in other
printing and coating regulations and CTGs (e.g., 40 CFR 60 Subpart FFF,
40 CFR 63 Subpart OOOO, and the 2006 Flexible Package Printing CTG),
where its use has been essentially interchangeable with the term press.
Although the printing operations are performed on a “press”, we need
to be clear that these other associated in-line activities and work
stations should be considered part of the printing operation.

(3) What does "auxiliary" mean?  Does it mean that it is not "in-line"?

If a coating is applied on a machine that is distinct and separate from
a "press", then maybe it should be within the scope of paper, film and
foil.  I am thinking of situations that parallel stand-alone equipment
(formerly stand-alone coating equipment) in the printing and publishing
MACT.  The printing and publishing MACT provided the owner/operator with
the choice of including stand-alone equipment in the printing and
publishing affected source or including it in an affected source under
another MACT (most likely paper and other web coating).  I don't recall
if we discussed this in the 2006 flexible packaging CTG.

ANSWER:  The term “ancillary” is perhaps more appropriate than
“auxiliary”. Ancillary coating would mean a process performed on
equipment and process units that are part of the overall printing and
packaging facility. This equipment could be either in-line or
stand-alone. The off-line ancillary operations perform a similar
function to in-line equipment and the materials used would be the same
as in-line materials.  We do not believe stand-alone equipment should be
covered by the paper, foil, and film CTG if the equivalent in-line
equipment is not.  Our view is that if the materials used on a press or
printing line are excluded from this CTG, then these same materials
should be excluded if applied on a stand alone piece of equipment.

(4) Why is "laminating" here? Does it add something that is not covered
by "adhesive"?

ANSWER:  Laminating activities are often found in flexographic and
digital operations and should therefore be considered part of the
printing operation.  Laminating typically involves solid materials and
may or may not involve an adhesive. Since coating is so broadly defined,
we believe it is important to include this activity in the definition.

(5) What is this sentence adding that is not covered by the previous
sentence?

ANSWER:  This sentence specifically identifies the materials, and not
the processes.  Due to EPA’s broad definition of coating materials, we
believe it is important to reiterate in the CTG that these materials,
when used in the printing and packaging processes, are excluded from
this source category and should not be subject to a future VOC content
limit.

(6) What does "these operations" means here?  Is it the same as "lines"

("presses") in the previous sentence? If so, why not say "lines"

("presses") here?

ANSWER:  The term “these operations” refers back to the press,
in-line, and ancillary operations.  Again, if the terms are sufficiently
defined to include these operations, then this sentence may not be
necessary.

 PAGE

 PAGE   2


[Federal Register Volume 88, Number 146 (Tuesday, August 1, 2023)]
[Notices]
[Pages 50139-50140]
[FR Doc No: 2023-16236]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC23-113-000.
    Applicants: GPS Cabazon Wind, LLC, Salka Cabazon HoldCo LLC.
    Description: Joint Application for Authorization Under section 203
of the Federal Power Act of GPS Cabazon Wind, LLC, et al.
    Filed Date: 7/24/23.
    Accession Number: 20230724-5228.
    Comment Date: 5 p.m. ET 8/14/23.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG23-239-000.
    Applicants: 7V Solar Ranch, LLC.
    Description: 7V Solar Ranch, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/21/23.
    Accession Number: 20230721-5177.
    Comment Date: 5 p.m. ET 8/11/23.

    Docket Numbers: EG23-240-000.
    Applicants: Crystal Hill Solar, LLC.
    Description: Crystal Hill Solar, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5108.
    Comment Date: 5 p.m. ET 8/15/23.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER23-22-002.
    Applicants: Puget Sound Energy, Inc.
    Description: Compliance filing: PSE Compliance Filng to be
effective 9/8/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5112.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-841-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing: Compliance Filing Revising Att V
Section 8 in Response to June 27 Order to be effective 4/1/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5025.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2334-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: 2198R34 Kansas Power Pool NITSA NOA
to be effective 9/1/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5084.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2477-000.
    Applicants: ISO New England Inc., Central Maine Power Company.
    Description: Sec.  205(d) Rate Filing: ISO New England Inc. submits
tariff filing per 35.13(a)(2)(iii: CMP; Request for Approval of Updated
Depreciation Rates to be effective 7/1/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5067.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2478-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2023-07-25 Attachment FF
Removal of MVP Limited Review to be effective 9/24/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5071.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2479-000.
    Applicants: American Electric Power Service Corporation, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: American Electric Power
Service Corporation submits tariff filing per 35.13(a)(2)(iii: AEP
submits update to Attachment 1 of ILDSA, SA No. 1336 (07/01/23) to be
effective 7/1/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5088.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2480-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: First Amendment GIA, Portal
Ridge Solar A-Cancel eTariff Record (WDT1517/SA1048) to be effective 7/
26/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5095.
    Comment Date: 5 p.m. ET 8/15/23.

    Docket Numbers: ER23-2481-000.
    Applicants: Crystal Hill Solar, LLC.
    Description: Baseline eTariff Filing: Market-Based Rate Application
to be effective 9/24/2023.
    Filed Date: 7/25/23.
    Accession Number: 20230725-5111.
    Comment Date: 5 p.m. ET 8/15/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: July 25, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-16236 Filed 7-31-23; 8:45 am]
BILLING CODE 6717-01-P


OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE PRODUCER QUARTERLY REPORT ( Sec 82.24)

SECTION 1 PRODUCING COMPANY IDENTIFICATION 1.1 Date of Submission 1.2 Quarter and Year to Which This Report Applies 1st 2nd 3rd 4th Year 1.3 Producing Company Company Name Street Address City State Zip Code 1.4 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number E mail Address 1.5 Importer Information Is your company an importer of class II substances? If yes, is the Importer Quarterly Report attached? Yes Yes No No 1.6 Exporter Information Is your company an exporter of class II substances? If yes, is the Exporter Quarterly Report attached? Yes Yes No No 1.7 Signature of Reporting Company Representative I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: For U. S. Postal Service:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 For Private Courier:

Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1310 L Street, NW, 8th Floor Washington, DC 20005 The public reporting and recordkeeping burden for this collection of information is estimated to average 4.5 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822T), 1200 Pennsylvania Ave., NW, Washington, D. C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.

Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE PRODUCER QUARTERLY REPORT ( Sec 82.24)

SECTION 2 COMPANY PRODUCTION DATA 2.1 Company Name 2.2 Company Production Totals A B C D E F G H I J Chemical Name Gross Production ( kg) In House Transformation ( kg) Second Party Transformation ( kg) In House Destruction ( kg) Second Party Destruction ( kg) HCFC 141b Exemption ( kg) Export Production ( kg) Article 5 Production ( kg) Net Production of HCFC ( kg)

( B  C  D  E   F = J)

HCFC 22 HCFC 123 HCFC 124 HCFC 133 HCFC 141b HCFC 142b HCFC 225ca HCFC 225cb If needed,

please write in HCFC not listed above Pending EPA ICR NUMBER 2014.03, Revised 4/ 06 OMB Control Number: 2060 0498 Pending Expiration Date: 6/ 30/ 06 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS II CONTROLLED SUBSTANCE PRODUCER QUARTERLY REPORT ( Sec 82.24)

SECTION 3 ALLOWANCE EXPENDITURE TOTALS 3.1 Company Name 3.2 Allowance Balance Summary A B C D E Total production allowances for year to date ( as of the end of the quarter) that were: Total consumption allowances for year to date ( as of the end of the quarter) that were: Total export production allowances for year to date ( as of the end of the quarter) that were: Total Article 5 allowances for year to date ( as of the end of the quarter) that were: Chemical Name Expended Unexpended Expended Unexpended Expended Unexpended Expended Unexpended HCFC 22 HCFC 123 HCFC 124 HCFC 133 HCFC 141b HCFC 142b HCFC 225ca HCFC 225cb If needed, please write in HCFC not listed above 3.3 Name( s) of HCFC 141b Exemption Allowance Holder( s) from whom Orders were Received and Associated Quantity ( kg) of HCFC 141b Requested and Produced Company Name: HCFC 141b Requested and Produced ( kg):

Company Name: HCFC 141b Requested and Produced ( kg):

Company Name: HCFC 141b Requested and Produced ( kg):

Company Name: HCFC 141b Requested and Produced ( kg):

Company Name: HCFC 141b Requested and Produced ( kg):

Pending EPA ICR NUMBER 2014.03, Revised 4/ 06


[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3294-3296]
[FR Doc No: 2022-01185]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2021-0415; FRL-9392-01-OCSPP]

Science Advisory Committee on Chemicals (SACC); Notice of Public
Meeting and Request for Comments on Draft Toxic Substances Control Act
(TSCA) Screening Level Approach for Assessing Ambient Air and Water
Exposures to Fenceline Communities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: There will be a 3-day public peer review virtual meeting of
the Science Advisory Committee on Chemicals (SACC) to consider and
review the draft EPA TSCA Screening Level Approach for Assessing
Ambient Air and Water Exposures to Fenceline Communities Version 1.0.
In addition, EPA is announcing the availability of and soliciting
public comments on the draft approach, which will be presented as a
screening level methodology for assessing potential air and water
chemical exposures to fenceline communities.

DATES:
    Virtual Public Meeting: Will be held March 15-17, 2022, from 10:00
a.m. to approximately 5:00 p.m. (EDT). See additional details and
instructions for registration that appear in Unit III.
    Written Comments: Submit your written comments on or before
February 22, 2022. As described in Unit III.
    Special accommodations: Request special accommodations on or before
February 20, 2022, to allow EPA time to process these requests.

ADDRESSES:
    Virtual Meeting: As described in Unit III., you must register
online to receive the webcast meeting link and audio teleconference
information. Please follow the registration instructions that will be
announced on the SACC website at https://www.epa.gov/tsca-peer-review
by early February 2022.
    Written Comments: Submit written comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2021-0415, through the Federal
eRulemaking Portal at http://www.regulations.gov. Follow the online
instructions for submitting comments. Do not electronically submit any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Copyrighted material will not be posted without explicit permission of
the copyright holder. Members of the public should also be aware that
personal information included in any written comments may be posted on
the internet at https://www.regulations.gov. Additional information on
commenting or visiting the docket, along with more information about
dockets generally, is available at https://www.epa.gov/dockets.
    Due to public health concerns related to COVID-19, the EPA Docket
Center and Reading Room are open to the public by appointment only. For
further information on the EPA Docket Center (EPA/DC) services, docket
contact information and the current status of the EPA/DC and Reading
Room, please visit https://www.epa.gov/dockets. For questions about
this docket, you may also contact the Designated Federal Official (DFO)
listed under FOR FURTHER INFORMATION CONTACT.
    Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr. Alaa Kamel, DFO, Office of
Chemical Safety and Pollution Prevention (7201M), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
and those interested in risk evaluations of chemical substances under
TSCA. Since other entities may also be interested in this action, the
EPA has not attempted to describe all the specific entities that may be
affected by this action.

B. Where can I access information about the SACC and this meeting?

    Information about the SACC and this meeting is available on the
SACC website at https://www.epa.gov/tsca-peer-review and in the docket
for this meeting, identified by docket ID number EPA-HQ-OPPT-2021-0415,
at https://www.regulations.gov. You may also subscribe to the following
listserv for alerts when notices regarding this and other SACC related
activities are published at https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT.

C. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at https://www.epa.gov/dockets.

II. Background

A. What is the purpose of the SACC?

    The SACC was established by EPA in 2016 and operates in accordance
with the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix 2 et
seq. The SACC provides expert independent scientific advice and
consultation to the EPA on the scientific and technical aspects of risk
assessments, methodologies, and pollution prevention measures and
approaches for chemicals regulated under TSCA.
    The SACC is comprised of experts in: Toxicology; Human health and
environmental risk assessment; Exposure assessment; and related
sciences (e.g., biology, chemistry, pharmacology, biotechnology,
nanotechnology, biochemistry, biostatistics, physiologically based
pharmacokinetic modelling (PBPK) modeling, computational toxicology,
epidemiology, environmental fate, and environmental engineering and
sustainability). When needed, the committee members will be assisted in
their reviews by consultants with specific expertise in the topics
under consideration.

B. What is the purpose of this virtual public meeting?

    The purpose of this virtual public meeting of the SACC is to
consider and review the draft document entitled ``EPA TSCA Screening
Level Approach for Assessing Ambient Air and Water Exposures to
Fenceline Communities Version 1.0,'' which will be presented as a
screening level methodology for assessing potential air and water
chemical exposures to fenceline communities.
    EPA published ten final risk evaluations between 2020 and 2021
under the Toxic Substances Control Act (TSCA) as amended by the Frank
R. Lautenberg Chemical Safety for the 21st Century Act in June 2016.
During the course of finalizing many of these first 10 risk
evaluations, a policy decision was made by the previous Administration
that EPA not assess air and water exposure pathways that fall under the
jurisdiction of other EPA-administered laws. This policy decision was
reversed in June 2021. EPA is presenting Version 1.0 of a screening
level methodology for assessing potential air and water pathway
chemical exposures to fenceline communities. Along with presenting this
methodology, EPA will also present results of applying the screening
methodology (case studies) to 1-Brompropane or 1-BP (air pathway), n-
methylpyrrolidone or NMP (water

pathway), and Methylene Chloride or MC (air and water pathway).

C. How can I access the documents submitted for review to the SACC?

    EPA's background documents, related supporting materials, and draft
charge questions to the SACC are available in the docket established
for this meeting at https://www.regulations.gov; docket ID number EPA-
HQ-OPPT-2021-0415 and on the SACC website. In addition, EPA will
provide additional background documents (e.g., SACC members and
consultants participating in this meeting and the meeting agenda) as
the materials become available. You may obtain electronic copies of
these documents, and certain other related documents that might be
available, in the docket at https://www.regulations.gov and the SACC
website at https://www.epa.gov/tsca-peer-review.
    After the public meeting, the SACC will prepare meeting minutes
summarizing its recommendations to the EPA. The meeting minutes will be
posted on the SACC website and in the docket.

III. Public Participation Instructions

    To participate in the Exposures to Fenceline Communities virtual
public meeting, please follow the instructions in this unit.

A. How can I provide comments for the SACC's consideration?

    To ensure proper receipt of comments it is imperative that you
identify docket ID No. EPA-HQ-OPPT-2021-0415 in the subject line on the
first page of your comments.
    1. Written comments. The Agency encourages written comments for
this meeting be submitted by the date set in the DATES section of this
document and using the additional instructions in ADDRESSES and Unit
I.B. and C. and Unit III, of this document. Anyone submitting written
comments after this date, should contact the DFO listed under FOR
FURTHER INFORMATION CONTACT. If you submit comments after the date set
in the DATES section, those comments will be provided to the SACC
members, but you should recognize that the SACC members may not have
adequate time to consider your written comments prior to their
discussion.
    2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to the SACC during the peer review
virtual meeting to please follow the registration instructions that
will be announced on the SACC website (https://www.epa.gov/tsca-peer-review) by early February 2022.
    Oral comments before the SACC during the peer review virtual
meeting are limited to 5 minutes unless arrangements have been made
prior to the date set in the DATES section. In addition, each speaker
should email a copy of his/her comments to the DFO prior to the meeting
for distribution to the SACC.

B. How can I participate in the virtual public meeting?

    This meeting is virtual and viewed via webcast. For information on
how to first register and then view the webcast, please refer to the
SACC website at https://www.epa.gov/tsca-peer-review. EPA intends to
announce registration instructions on the SACC website by early
February 2022.
    Authority: 15 U.S.C. 2601 et seq.

    Dated: January 18, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemicals Safety and Pollution
Prevention.
[FR Doc. 2022-01185 Filed 1-20-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 167 (Wednesday, August 28, 2019)]
[Notices]
[Pages 45144-45145]
[FR Doc No: 2019-18476]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR19-33-000]

Tesoro Refining & Marketing Company LLC; Western Refining
Company, L.P. v. SFPP, L.P.; Notice of Complaint

    Take notice that July 22, 2019, pursuant to Rule 206 of the Rules
of Practice and Procedure of the Federal Energy Regulatory Commission
(Commission),\1\ section 343.2 of the Procedural Rules Applicable to
Oil Pipeline Proceedings,\2\ and sections 1(5), 8, 9, 13, 15, and 16 of
the Interstate Commerce Act,\3\ Western Refining Company, L.P.
(Western) and Tesoro Refining & Marketing Company LLC (Tesoro)
(collectively, Complainants) hereby file a complaint against SFPP, L.P.
(SFPP), challenging the justness and reasonableness of SFPP's West Line
(Tariff No. 198.20.0), East Line (Tariff No. 197.13.0), North Line
(Tariff No. 199.9.0), and Oregon Line (Tariff No.

200.12.0) index increases taken in 2018. Complainants allege that
SFPP's rates for this transportation are unjust and unreasonable and
request that the Commission investigate SFPP's rates, set the
proceedings for an evidentiary hearing to determine the just and
reasonable rates for SFPP's index rate increases, require SFPP to pay
reparations starting two years before the date of the Complaint for all
rates, and award such other relief as is necessary and appropriate
under the Interstate Commerce Act, all as more fully explained in the
complaint.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.206.
    \2\ 18 CFR 343.2.
    \3\ 49 U.S.C. App. 1(5), 8, 9, 13, 15 and 16 (1988).
---------------------------------------------------------------------------

    Complainants certify that copies of the complaint were served on
the contacts listed for Respondent on the Commission's list of
Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 19, 2019.

    Dated: August 21, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-18476 Filed 8-27-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60152-60153]
[FR Doc No: 2020-21104]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-3115-006.
    Applicants: Waterside Power, LLC.
    Description: Third Supplement to April 20, 2020 Triennial Market
Power Update for the Northeast Region of Waterside Power, LLC.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5141.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER10-3115-007.
    Applicants: Waterside Power, LLC.
    Description: Supplement to June 30, 2020 Updated Market Power
Analysis of Waterside Power, LLC.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5140.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER10-3117-008.
    Applicants: Lea Power Partners, LLC.
    Description: Third Supplement to April 20, 2020 Triennial Market
Power Update for the Southwest Power Pool Region of Lea Power Partners,
LLC.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5144.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER13-445-009; ER11-4060-009; ER11-4061-009; ER14-
2823-007; ER15-1170-005; ER15-1171-005; ER15-1172-005; ER15-1173-005.
    Applicants: Badger Creek Limited, Bear Mountain Limited, Chalk
Cliff Limited, Double C Generation Limited Partnership, High Sierra
Limited, Kern Front Limited, Live Oak Limited, McKittrick Limited.
    Description: Second Supplement to April 20, 2020 Triennial Market
Power Update for the Southwest Power Pool Region of Badger Creek
Limited, et al.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5128.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER19-1955-004.
    Applicants: Public Service Company of New Mexico.
    Description: Compliance filing: Order No. 845 Compliance Filing to
be effective 5/22/2019.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5133.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER19-1958-003.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Third Compliance filing per
Commission's 5/21/20 order in Docket No. ER19-1958 to be effective 7/
20/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5024.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER19-1959-002.
    Applicants: Avista Corporation.
    Description: Compliance filing: Avista Corp OATT Order 845/845A
Compliance Filing to be effective 10/17/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5122.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER19-2745-002.
    Applicants: New Creek Wind LLC.
    Description: Report Filing: Refund Report Under Docket ER19-2745 to
be effective N/A.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5051.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-687-001.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Compliance filing: Order Nos. 845 and 845-A Second
Compliance Filing to be effective 2/25/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5132.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-1648-002.
    Applicants: Inter-Power/AhlCon Partners, L.P.
    Description: Notice of Change in Status of Inter-Power/AhlCon
Partners, L.P.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5184.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER20-2519-000.
    Applicants: East Line Solar, LLC.
    Description: Supplement to July 28, 2020 East Line Solar, LLC
tariff filing.
    Filed Date: 9/9/20.
    Accession Number: 20200909-5179.
    Comments Due: 5 p.m. ET 9/21/20.

    Docket Numbers: ER20-2911-000.
    Applicants: Appalachian Power Company.
    Description: Tariff Cancellation: Notice of Cancellation AEPSC-Wolf
Hills Energy Interconnection & Operation Agrmt to be effective 11/21/
2020.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5113.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER20-2912-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits revised IA SA
Nos. 3993 to be effective 11/18/2020.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5127.
    Comments Due: 5 p.m. ET 10/8/20.

    Docket Numbers: ER20-2914-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Request for Waiver of Tariff Provisions, et al. of PJM
Interconnection, L.L.C.
    Filed Date: 9/17/20.
    Accession Number: 20200917-5176.
    Comments Due: 5 p.m. ET 9/22/20.

    Docket Numbers: ER20-2915-000.
    Applicants: NSTAR Electric Company.
    Description: Tariff Cancellation: Cancellation of Vineyard Wind
Design

and Engineering Agreement to be effective 7/10/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5095.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2916-000.
    Applicants: Alabama Power Company.
    Description: Tariff Cancellation: Bird Dog Solar LGIA Termination
Filing to be effective 9/18/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5102.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2917-000.
    Applicants: Alabama Power Company.
    Description: Tariff Cancellation: Bulldog Solar (Bulldog Solar I)
LGIA Termination Filing to be effective 9/18/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5103.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2918-000.
    Applicants: Alabama Power Company.
    Description: Tariff Cancellation: Sonny Solar LGIA Termination
Filing to be effective 9/18/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5104.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2919-000.
    Applicants: Tri-State Generation and Transmission Association, Inc.
    Description: Request for One-Time, Limited Waiver of Tariff
Provision, et al. of Tri-State Generation and Transmission Association,
Inc.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5127.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2920-000.
    Applicants: Public Service Company of New Mexico.
    Description: Sec.  205(d) Rate Filing: OATT Revisions to Attachment
A-1 to be effective 11/18/2020.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5128.
    Comments Due: 5 p.m. ET 10/9/20.

    Docket Numbers: ER20-2921-000.
    Applicants: Glidepath Ventures, LLC.
    Description: Petition for Waiver, et al. of Glidepath Ventures,
LLC.
    Filed Date: 9/18/20.
    Accession Number: 20200918-5129.
    Comments Due: 5 p.m. ET 10/2/20.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: September 18, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-21104 Filed 9-23-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Notices]
[Pages 8091-8092]
[FR Doc No: 2015-03004]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1049]

Conditional Approval of New Animal Drugs; Public Meeting; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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

    The Food and Drug Administration (FDA) is announcing a public
meeting to explore the use of statutory changes to expand the use of
conditional approval to additional categories of new animal drugs. This
policy exploration is consistent with a stated performance goal in the
Animal Drug User Fee Amendments of 2013 (ADUFA III) goals letter. FDA
is requesting that you submit any comments related to this issue by
September 30, 2015.
    Date and Time: The public meeting will be held on March 16, 2015,
from 1 p.m. until 4 p.m.
    Location: The public meeting will be held at the Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
3rd Floor, Rockville, MD 20855. Parking is free.
    Contact Person: Laura Bradbard, Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rm. 159, Rockville, MD
20855,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this meeting must
register by March 10, 2015. For general questions about the meeting,
for assistance to register for the meeting, to request an opportunity
to make an oral presentation, or to request special accommodations due
to a disability, contact Laura Bradbard (see Contact Person). Please
include your name, organization, and contact information. If you are
requesting an opportunity to speak, please send a brief summary of your
comments. Early registration for the meeting is encouraged due to
limited time and space.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA considers the timely review of the safety and effectiveness of
new animal drugs to be central to the Agency's mission to protect and
promote the public health. Before 2004, the timeliness and
predictability of the new animal drug review program was a concern. The
Animal Drug User Fee Act enacted in 2003 (Pub. L. 108-130; hereinafter
referred to as ``ADUFA I''), authorized FDA to collect user fees for 5
years--fiscal year (FY) 2004 to FY 2008--that were to be dedicated to
expediting the review of new animal drug applications according to
certain performance goals and to expand and modernize the new animal
drug review program. The Agency agreed to meet a comprehensive set of
performance goals established to show significant improvement in the
timeliness and predictability of the new animal drug review process.
The implementation of ADUFA I provided a significant funding increase
that enabled FDA to increase the number of staff dedicated to the new
animal drug application review process.
    In 2008, before ADUFA I expired, Congress passed the Animal Drug
User Fee Amendments of 2008 (Pub. L. 110-316; hereinafter referred to
as ``ADUFA II''), which included an extension of ADUFA for an
additional 5 years--FY 2009 to FY 2013. ADUFA II performance goals were
established based on ADUFA I FY 2008 review timeframes. In addition,
FDA provided program enhancements to reduce review cycles and improve
communications during reviews.
    In 2013, before ADUFA II expired, Congress passed ADUFA III (Pub.
L. 113-14), which was signed by the President on June 13, 2013. Like
its predecessors, ADUFA III includes its own comprehensive set of
performance goals. One such goal, as stated in the ADUFA III goals
letter, is: Beginning in early FY 2014, the Agency agrees to explore,
in concert with industry, the feasibility of pursuing statutory
revisions, consistent with the Agency's mission to protect and promote
the public health, that may expand the use of conditional approvals to
other appropriate categories of new animal drug applications and
develop recommendations by September 30, 2015.
    Currently, the conditional approval provisions allow an applicant
to market a new animal drug intended for a minor species or a minor use
in a major species after the applicant has demonstrated that the drug
is safe and can be manufactured according to standards applicable to
approval of applications under section 512(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(b)(1)). FDA and members of
regulated industry jointly agreed to explore, as part of the
performance goals outlined in the ADUFA III goals letter, statutory
changes to expand the use of conditional approval to other appropriate
categories of new animal drugs.
    This public meeting is intended to provide an additional
opportunity for public comment. The Agency is especially interested in
receiving comments during the meeting on the categories of new animal
drug applications that would be considered ``appropriate'' and why;
concerns, if any, that might arise due to the expansion of the
Conditional Approval process; and the length of marketing exclusivity,
if any, that should be associated with the expansion of the Conditional
Approval process.
    FDA will consider comments received at this meeting as it moves
forward with this process.
    FDA has already opened public docket FDA Docket No. FDA-2014-N-1049
to receive comments on the issue (79 FR 53430, September 9, 2014).
Although you can comment on this document at any time, to ensure that
the Agency considers your comment before finalizing work on the
exploration process described in this document, submit either
electronic or written comments by September 30, 2015.

II. Participation in a Public Meeting

    While oral presentations from specific individuals and
organizations may be limited due to time constraints during the public
meeting, stakeholders may submit electronic or written comments
discussing any issues of concern to the administration record (the
docket). All relevant data and documentation should be submitted with
the comments to Docket No. FDA-2014-N-1049. Submit electronic comments
to http://www.regulations.gov. Submit written comments to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to
send one set of comments. Identify comments with the docket number FDA-
2014-N-1049. Received comments may be seen in the Division

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

III. Comments, Transcripts, and Recorded Video

    Information and data submitted voluntarily to FDA during the public
meeting will become part of the administrative record and will be
accessible to the public at http://www.regulations.gov. The transcript
of the proceedings from the public meeting will become part of the
administrative record. Please be advised that as soon as a transcript
is available, it will be accessible at http://www.regulations.gov,
Docket No. FDA-2014-N-1049, and at FDA's CVM Web site at: http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm. It may also be viewed at the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to the Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville, MD 20857. Additionally, FDA
will be recording the meeting via Adobe Connect on March 16, 2015. Once
the recording has been made 508 compliant, it will be accessible at
FDA's CVM Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/ucm042891.htm.

    Dated: February 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03004 Filed 2-12-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 31, 2008 (Volume 73, Number 62)]
[Notices]
[Page 16946-16950]
[DOCID:fr31mr08-131]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket ID. FMCSA-2008-0071]

Qualification of Drivers; Exemption Applications; Diabetes

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

ACTION: Notice of applications for exemptions from the diabetes
standard; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 29 individuals
for exemptions from the prohibition against persons with insulin-
treated diabetes mellitus (ITDM) operating commercial motor vehicles
(CMVs) in interstate commerce. If granted, the exemptions would enable
these individuals with ITDM to operate commercial motor vehicles in
interstate commerce.

DATES: Comments must be received on or before April 30, 2008.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-2008-0071 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket ID for
this Notice. Note that DOT posts all comments received without change
to http://www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    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 on-line.
    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 19477-78; Apr. 11, 2000).
This information is also available at http://Docketinfo.dot.gov.

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:

Background

    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 statutes also allow the
Agency to renew exemptions at the end of the 2-year period. The 29
individuals listed in this notice have recently requested an exemption
from the diabetes prohibition in 49 CFR 391.41(b)(3), which applies to
drivers of CMVs in interstate commerce. Accordingly, the Agency will
evaluate the qualifications of each applicant to determine whether
granting the

exemption will achieve the required level of safety mandated by the
statutes.

Qualifications of Applicants

Gary D. Coonfield

    Mr. Coonfield, age 45, has had ITDM since 2003. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Coonfield meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A Commercial Driver's License
(CDL) from Wisconsin.

Edward F. Connole

    Mr. Connole, 53, has had ITDM since 2007. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Connole meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Massachusetts.

Jason C. Daily

    Mr. Daily, 37, has had ITDM since 1990. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Daily meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class C operator's license from New
Hampshire.

Mark B. Demmer

    Mr. Demmer, 44, has had ITDM since 2006. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Demmer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Washington.

Francis W. Devine

    Mr. Devine, 66, has had ITDM since 2007. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Devine meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from New Jersey.

Paul W. Dietz

    Mr. Dietz, 45, has had ITDM since 2007. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Dietz meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Pennsylvania.

Harold W. Goodwill

    Mr. Goodwill, 50, has had ITDM since 2003. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Goodwill meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class B CDL from Pennsylvania.

Shannon D. Hanson

    Mr. Hanson, 37, has had ITDM since 1975. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hanson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class A CDL from
South Dakota.

Craig A. Hendrickson

    Mr. Hendrickson, 39, has had ITDM since 2007. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Hendrickson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class D operator's license from
Illinois.

Michael T. Johnson

    Mr. Johnson, 34, has had ITDM since 1992. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using

insulin, and is able to drive a CMV safely. Mr. Johnson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Michael K. Limberg

    Mr. Limberg, 54, has had ITDM since 1973. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Limberg meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he has stable
proliferative and nonproliferative diabetic retinopathy. He holds a
Class O operator's license from Nebraska, which allows him to drive any
non-commercial vehicle except motorcycles.

Maurice R. McGill, Jr.

    Mr. McGill, 53, has had ITDM since 2001. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. McGill meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class B CDL from
Pennsylvania.

Aundra Menefield

    Mr. Menefield, 50, has had ITDM since 2001. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Menefield meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Mississippi.

Charles E. Murphy

    Mr. Murphy, 46, has had ITDM since 2001. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Murphy meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Ohio.

Eric B. Pies

    Mr. Pies, 44, has had ITDM since 1985. His endocrinologist examined
him in 2007 and certified that he has had no hypoglycemic reactions
resulting in loss of consciousness, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning in the past 5 years; understands diabetes management
and monitoring; and has stable control of his diabetes using insulin,
and is able to drive a CMV safely. Mr. Pies meets the requirements of
the vision standard at 49 CFR 391.41(b)(10). His ophthalmologist
examined him in 2007 and certified that he has stable nonproliferative
diabetic retinopathy. He holds a Class C operator's license from
Oregon.

Douglas G. Puckett

    Mr. Puckett, 65, has had ITDM since 2006. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Puckett meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Virginia.

Eric A. Quisling

    Mr. Quisling, 37, has had ITDM since 1986. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Quisling meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

James T. Rothwell

    Mr. Rothwell, 38, has had ITDM since 1984. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Rothwell meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he has stable
nonproliferative diabetic retinopathy. He holds a Class D operator's
license from Tennessee.

Bob L. Rumble

    Mr. Rumble, 61, has had ITDM since 2004. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Rumble meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Idaho.

Larry D. Schweisberger

    Mr. Schweisberger, 55, has had ITDM since 2001. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another

person, or resulting in impaired cognitive function that occurred
without warning in the past 5 years; understands diabetes management
and monitoring; and has stable control of his diabetes using insulin,
and is able to drive a CMV safely. Mr. Schweisberger meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class B CDL from Missouri.

Randy A. Shannon

    Mr. Shannon, 44, has had ITDM since 2004. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Shannon meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2008 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Montana.

Dalton T. Smith, Jr.

    Mr. Smith, 44, has had ITDM since 2004. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Smith meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from Illinois.

Kim M. Stickelmeyer

    Ms. Stickelmeyer, 53, has had ITDM since 2007. Her endocrinologist
examined her in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of her diabetes using
insulin, and is able to drive a CMV safely. Ms. Stickelmeyer meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). Her
optometrist examined her in 2007 and certified that she does not have
diabetic retinopathy. She holds a Class A CDL from Washington.

Marvin D. Webster

    Mr. Webster, 44, has had ITDM since 2003. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Webster meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Kentucky.

Harold A. Wendt

    Mr. Wendt, 72, has had ITDM since 2004. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wendt meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class A operator's license from
Minnesota.

Donald D. Willard

    Mr. Willard, 62, has had ITDM since 1982. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Willard meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Iowa.

Anthony O. Wilson

    Mr. Wilson, 45, has had ITDM since 1985. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wilson meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
optometrist examined him in 2007 and certified that he does not have
diabetic retinopathy. He holds a Class A CDL from Georgia.

Travis S. Wolfe

    Mr. Wolfe, 26, has had ITDM since 2006. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wolfe meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2008 and certified that he does not
have diabetic retinopathy. He holds a Class A CDL from West Virginia.

Jason J. Wolff

    Mr. Wolff, 34, has had ITDM since 1983. His endocrinologist
examined him in 2007 and certified that he has had no hypoglycemic
reactions resulting in loss of consciousness, requiring the assistance
of another person, or resulting in impaired cognitive function that
occurred without warning in the past 5 years; understands diabetes
management and monitoring; and has stable control of his diabetes using
insulin, and is able to drive a CMV safely. Mr. Wolff meets the
requirements of the vision standard at 49 CFR 391.41(b)(10). His
ophthalmologist examined him in 2007 and certified that he does not
have diabetic retinopathy. He holds a Class D operator's license from
Minnesota.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. We will consider all comments received before
the close of

business on the closing date indicated in the dates section of the
Notice.
    FMCSA notes that section 4129 of the Safe, Accountable, Flexible
and Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-
LU) requires the Secretary to revise its diabetes exemption program
established on September 3, 2003 (68 FR 52441).\1\ The revision must
provide for individual assessment of drivers with diabetes mellitus,
and be consistent with the criteria described in section 4018 of the
Transportation Equity Act for the 21st Century (49 U.S.C. 31305).
---------------------------------------------------------------------------

    \1\ Section 4129(a) refers to the 2003 Notice as a ``final
rule.'' However, the 2003 Notice did not issue a ``final rule'' but
did establish the procedures and standards for issuing exemptions
for drivers with ITDM.
---------------------------------------------------------------------------

    Section 4129 requires: (1) The elimination of the requirement for
three years of experience operating CMVs while being treated with
insulin; and (2) the establishment of a specified minimum period of
insulin use to demonstrate stable control of diabetes before being
allowed to operate a CMV.
    In response to section 4129, FMCSA made immediate revisions to the
diabetes exemption program established by the September 3, 2003 Notice.
FMCSA discontinued use of the 3-year driving experience and fulfilled
the requirements of section 4129 while continuing to ensure that
operation of CMVs by drivers with ITDM will achieve the requisite level
of safety required of all exemptions granted under 49 USC. 31136 (e).
    Section 4129(d) also directed FMCSA to ensure that drivers of CMVs
with ITDM are not held to a higher standard than other drivers, with
the exception of limited operating, monitoring and medical requirements
that are deemed medically necessary. FMCSA concluded that all of the
operating, monitoring and medical requirements set out in the September
3, 2003 Notice, except as modified, were in compliance with section
4129(d). Therefore, all of the requirements set out in the September 3,
2003 Notice, except as modified by the Notice in the Federal Register
on November 8, 2005 (70 FR 67777), remain in effect.
    The Agency announces a correction regarding Jonathan B. Estridge, a
Federal diabetes exemption applicant who was first published in a
notice for comments on February 1, 2008 (73 FR 6251). There were no
comments to the docket regarding granting him an exemption but he was
omitted from the notice of final disposition that was published on
March 12, 2008. Therefore, he will be granted an exemption with an
effective date of March 12, 2008.

    Dated: March 21, 2008.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. E8-6478 Filed 3-28-08; 8:45 am]

BILLING CODE 4910-EX-P


Stefano C Crema < cremas@ basfcorp com>

11/ 21/ 2003 12: 51 PM To: Jeff Herzog/ AA/ USEPA/ US@ EPA cc: Subject: Re: Solvent 124 Jeff,

nice to hear from you that the yellow 124 is still the preferred approach.

I have briefly spoken with our people in Europe and they said it is common over there to mix the red dye and the Yellow 124 in the right ration and then inject them together. Therefore no new equipment is needed in the specific cases you mention below.

As to the patent question, I would like to point out that BASF does not have a patent on yellow 124 manufacture but on the use of the combination yellow 124 with a red dye in diesel fiscal applications. Furthermore, we have given royalty free licences in Europe and I would bet that the same thing would be done here in the US Further information will be sent to you monday or Tuesday..

Have a nice weekend.

Herzog. Jeff@ epama il. epa. gov To: Stefano C Crema cc: 11/ 20/ 2003 09: 41 Subject: Solvent Yellow 124 AM Hello Dr. Crema,

Alex related that he had moved on to another assignment and that I should contact you with questions re solvent yellow 124. We are still seriously considering finalizing fuel marker requirements under the NR rule and SY 124 continues to be a candidate. Currently, we are evaluating comments from terminal operators that requiring the addition of a marker at the terminal would force them to put in a new segregated dedicated additive injection equipment on each fuel loading arm.

* Certain terminals are likely to handle only heating oil ( and no other non highway fuels). For these terminals, every batch of fuel that would be required to contain red dye would also be required to contain SY 124. In such cases, I am wondering whether it would be possible to mix the marker with the red dye in the same storage tank ( at the proper proportions) and adjust the injection rate so that both products could be delivered at their respective required concentrations through the same injection system. This approach would mean that there would be no new capitol costs for such terminals. Are you aware of any technical or other considerations that would prevent such an approach? Terminal operators related that the cost for new injection equipment would $ 40,000 a loading arm with the cost for some terminals being as much as $ 250,000 ( for 6 7 loading arms). I am in communication with injection equipment manufactures regarding the potential options and associated costs. Currently it isn't clear to me whether a complete duplicate system would be needed. I am evaluating whether it may be possible to inject the marker into the feed stream from the heating oil storage tank, followed by a flush of the loading arm used to ensure that their was no residual SY 124 left in the loading arm to contaminate a following batch of NRLM fuel dispensed through the loading arm ( that must not show evidence of the marker). If such an approach was possible, it might result in a significant cost savings wrt the need for new injection equipment.

Are you aware of how the injection systems are set up in the EU to handle the injection of the solvent yellow 124 marker and the various other fiscal dyes required? Our situation would have red dye added to all non highway fuels, but solvent yellow added only one type of fuel which is required to contain red dye.... In the EU, I believe that all fuels that must contain the fiscal dye must also contain the marker ... Can you confirm this?

Also, I believe that in discussions with Alex that BASF's patent on solvent yellow 124 would expire before the use of the proposed marker would be required ( terminals would need to build their stocks in early of 2007). Can you tell me the date when the patent expires and give the patent # so that I can reference it? The public comments expressed concern about EPA requiring the use of a proprietary substance that could only be manufactured by parties ( other than the patent holder) by paying a licence fee. This would no longer be an issue if the patent had expired.

I received some estimated marker costs from a major marketer of fuel marker/ dyes. They estimated that a good estimate re the cost for bulk deliveries of SY 124 to terminals would translate to a treatment cost ( at 6mg/ liter) of 0.03 cents per gallon. Can you comment on this?

My immediate interest is focused on answering the question in the paragraph marked with the asterisk.

I appreciate your help working through these issues. Jeffrey A. Herzog, Mechanical Engineer United States Environmental Protection Agency National Vehicle and Fuel Emissions Laboratory Assessment and Standards Division 2000 Traverwood Drive Ann Arbor, Michigan, 48105 Phone: ( 734) 214 4227 Fax: ( 734) 214 4816 E Mail: herzog. jeff@ epa. gov


[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Rules and Regulations]
[Page 81744]
[FR Doc No: 2015-33047]

=======================================================================
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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Part 774

The Commerce Control List

CFR Correction

    In Title 15 of the Code of Federal Regulations, Parts 300 to 799,
revised as of January 1, 2015, on page 999, in Supplement 1 to Part
774, in Category 9, Export Control Classification Number (ECCN) 9E003,
in the Items section, remove the second introductory text of paragraph
f.1.

[FR Doc. 2015-33047 Filed 12-30-15; 8:45 am]
 BILLING CODE 1505-01-D