[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62793-62795]
[FR Doc No: 2020-21898]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1998-3637; FMCSA-1999-6480; FMCSA-2000-7165; FMCSA-
2000-8203; FMCSA-2002-12294; FMCSA-2003-16564; FMCSA-2005-22194; FMCSA-
2006-23773; FMCSA-2008-0266; FMCSA-2009-0206; FMCSA-2009-0291; FMCSA-
2010-0201; FMCSA-2011-0379; FMCSA-2014-0002; FMCSA-2014-0004; FMCSA-
2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0297; FMCSA-
2016-0029; FMCSA-2016-0031; FMCSA-2016-0033; FMCSA-2016-0206; FMCSA-
2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-0210; FMCSA-
2017-0017; FMCSA-2018-0010; FMCSA-2018-0011; FMCSA-2018-0017; FMCSA-
2018-0018]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew exemptions for 42
individuals from the vision requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these individuals to continue to
operate CMVs in interstate commerce without meeting the vision
requirements in one eye.

DATES: Each group of renewed exemptions are applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before November
4, 2020.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-1998-3637, Docket No. FMCSA-
1999-6480, Docket No. FMCSA-2000-7165, Docket No. FMCSA-2000-8203,
Docket No. FMCSA-2002-12294, Docket No. FMCSA-2003-16564, Docket No.
FMCSA-2005-22194, Docket No. FMCSA-2006-23773, Docket No. FMCSA-2008-
0266, Docket No. FMCSA-2009-0206, Docket No. FMCSA-2009-0291, Docket
No. FMCSA-2010-0201, Docket No. FMCSA-2011-0379, Docket No. FMCSA-2014-
0002, Docket No. FMCSA-2014-0004, Docket No. FMCSA-2014-0006, Docket
No. FMCSA-2014-0007, Docket No. FMCSA-2014-0010, Docket No. FMCSA-2014-
0297, Docket No. FMCSA-2016-0029, Docket No. FMCSA-2016-0031, Docket
No. FMCSA-2016-0033, Docket No. FMCSA-2016-0206, Docket No. FMCSA-2016-
0207, Docket No. FMCSA-2016-0208, Docket No. FMCSA-2016-0209, Docket
No. FMCSA-2016-0210, Docket No. FMCSA-2017-0017, Docket No. FMCSA-2018-
0010, Docket No. FMCSA-2018-0011, Docket No. FMCSA-2018-0017, or Docket
No. FMCSA-2018-0018 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Operations; 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.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<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.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-1998-3637; FMCSA-1999-6480; FMCSA-2000-7165;
FMCSA-2000-8203; FMCSA-2002-12294; FMCSA-2003-16564; FMCSA-2005-22194;
FMCSA-2006-23773; FMCSA-2008-0266; FMCSA-2009-0206; FMCSA-2009-0291;
FMCSA-2010-0201; FMCSA-2011-0379; FMCSA-2014-0002; FMCSA-2014-0004;
FMCSA-2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0297;
FMCSA-2016-0029; FMCSA-2016-0031; FMCSA-2016-0033; FMCSA-2016-0206;
FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-0210;
FMCSA-2017-0017; FMCSA-2018-0010; FMCSA-2018-0011; FMCSA-2018-0017;
FMCSA-2018-0018), indicate the specific section of this document to
which each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online or by
fax, mail, or hand delivery, but please use only one of these means.
FMCSA recommends that you include your name and a mailing address, an
email address, or a phone number in the body of your document so that
FMCSA can contact you if there are questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-1998-3637; FMCSA-1999-6480; FMCSA-2000-
7165; FMCSA-2000-8203; FMCSA-2002-12294; FMCSA-2003-16564; FMCSA-2005-
22194; FMCSA-2006-23773; FMCSA-2008-0266; FMCSA-2009-0206; FMCSA-2009-
0291; FMCSA-2010-0201; FMCSA-2011-0379; FMCSA-2014-0002; FMCSA-2014-
0004; FMCSA-2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-
0297; FMCSA-2016-0029; FMCSA-2016-0031; FMCSA-2016-0033; FMCSA-2016-
0206; FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-
0210; FMCSA-2017-0017; FMCSA-2018-0010; FMCSA-2018-0011; FMCSA-2018-
0017; FMCSA-2018-0018, in the keyword box, and click ``Search.'' When
the new screen appears, click on the ``Comment Now!'' button and type
your comment into the text box on the following screen. Choose whether
you are submitting your comment as an individual or on behalf of a
third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-1998-3637; FMCSA-1999-6480; FMCSA-2000-
7165; FMCSA-2000-8203; FMCSA-2002-12294; FMCSA-2003-16564;

FMCSA-2005-22194; FMCSA-2006-23773; FMCSA-2008-0266; FMCSA-2009-0206;
FMCSA-2009-0291; FMCSA-2010-0201; FMCSA-2011-0379; FMCSA-2014-0002;
FMCSA-2014-0004; FMCSA-2014-0006; FMCSA-2014-0007; FMCSA-2014-0010;
FMCSA-2014-0297; FMCSA-2016-0029; FMCSA-2016-0031; FMCSA-2016-0033;
FMCSA-2016-0206; FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209;
FMCSA-2016-0210; FMCSA-2017-0017; FMCSA-2018-0010; FMCSA-2018-0011;
FMCSA-2018-0017; FMCSA-2018-0018, in the keyword box, and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Operations in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday
through Friday, except Federal holidays.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.
    The 42 individuals listed in this notice have requested renewal of
their exemptions from the vision standard in Sec.  391.41(b)(10), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 42
applicants has satisfied the renewal conditions for obtaining an
exemption from the vision standard (see 63 FR 196; 63 FR 30285; 64 FR
68195; 65 FR 20251; 65 FR 33406; 65 FR 57234; 65 FR 66293; 67 FR 38311;
67 FR 46016; 67 FR 57266; 67 FR 57267; 67 FR 67234; 68 FR 74699; 69 FR
10503; 69 FR 26921; 69 FR 51346; 69 FR 52741; 69 FR 62741; 70 FR 57353;
70 FR 72689; 71 FR 6828; 71 FR 6829; 71 FR 19604; 71 FR 27033; 71 FR
50970; 71 FR 53489; 71 FR 62147; 73 FR 27018; 73 FR 36955; 73 FR 42403;
73 FR 48270; 73 FR 51336; 73 FR 51689; 73 FR 63047; 73 FR 74565; 74 FR
43217; 74 FR 57551; 74 FR 65842; 75 FR 9482; 75 FR 36779; 75 FR 38602;
75 FR 50799; 75 FR 52062; 75 FR 54958; 75 FR 64396; 75 FR 66423; 75 FR
70078; 76 FR 66123; 77 FR 10604; 77 FR 15184; 77 FR 27850; 77 FR 38384;
77 FR 40946; 77 FR 48590; 77 FR 52389; 77 FR 64582; 77 FR 68199; 77 FR
68200; 78 FR 77782; 79 FR 10608; 79 FR 10619; 79 FR 18392; 79 FR 22003;
79 FR 29498; 79 FR 35212; 79 FR 35218; 79 FR 38659; 79 FR 38661; 79 FR
45868; 79 FR 46300; 79 FR 47175; 79 FR 51643; 79 FR 53514; 79 FR 56104;
79 FR 59357; 79 FR 63211; 79 FR 64001; 79 FR 68199; 80 FR 2471; 81 FR
20435; 81 FR 28138; 81 FR 42054; 81 FR 52514; 81 FR 59266; 81 FR 60115;
81 FR 66722; 81 FR 68098; 81 FR 70248; 81 FR 70251; 81 FR 70253; 81 FR
71173; 81 FR 72642; 81 FR 72664; 81 FR 74494; 81 FR 80161; 81 FR 81230;
81 FR 90046; 81 FR 90050; 81 FR 94013; 81 FR 96178; 81 FR 96191; 81 FR
96196; 82 FR 20962; 82 FR 37499; 83 FR 18633; 83 FR 24585; 83 FR 28325;
83 FR 28332; 83 FR 28342; 83 FR 34661; 83 FR 34677; 83 FR 40638; 83 FR
45750; 83 FR 53724; 83 FR 53727; 83 FR 56137; 83 FR 56902; 84 FR 2328).
They have submitted evidence showing that the vision in the better eye
continues to meet the requirement specified at Sec.  391.41(b)(10) and
that the vision impairment is stable. In addition, a review of each
record of safety while driving with the respective vision deficiencies
over the past 2 years indicates each applicant continues to meet the
vision exemption requirements. These factors provide an adequate basis
for predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of November
and are discussed below. As of November 9, 2020, and in accordance with
49 U.S.C. 31136(e) and 31315, the following 30 individuals have
satisfied the renewal conditions for obtaining an exemption from the
vision requirement in the FMCSRs for interstate CMV drivers (63 FR 196;
63 FR 30285; 64 FR 68195; 65 FR 20251; 65 FR 33406; 65 FR 57234; 65 FR
66293; 67 FR 38311; 67 FR 46016; 67 FR 57266; 67 FR 57267; 67 FR 67234;
68 FR 74699; 69 FR 10503; 69 FR 26921; 69 FR 51346; 69 FR 52741; 69 FR
62741; 70 FR 57353; 70 FR 72689; 71 FR 6828; 71 FR 6829; 71 FR 19604;
71 FR 27033; 71 FR 50970; 71 FR 53489; 71 FR 62147; 73 FR 27018; 73 FR
36955; 73 FR 42403; 73 FR 48270; 73 FR 51336; 73 FR 51689; 73 FR 63047;
73 FR 74565; 74 FR 43217; 74 FR 57551; 74 FR 65842; 75 FR 9482; 75 FR
36779; 75 FR 38602; 75 FR 50799; 75 FR 52062; 75 FR 54958; 75 FR 64396;
75 FR 66423; 75 FR 70078; 76 FR 66123; 77 FR 10604; 77 FR 15184; 77 FR
27850; 77 FR 38384; 77 FR 40946; 77 FR 48590; 77 FR 52389; 77 FR 64582;
77 FR 68199; 77 FR 68200; 78 FR 77782; 79 FR 10608; 79 FR 10619; 79 FR
18392; 79 FR 2200379 FR 29498; 79 FR 35212; 79 FR 35218; 79 FR 38659;
79 FR 38661; 79 FR 45868; 79 FR 46300; 79 FR 47175; 79 FR 51643; 79 FR
53514; 79 FR 56104; 79 FR 59357; 79 FR 64001; 79 FR 68199; 81 FR 20435;
81 FR 28138; 81 FR 42054; 81 FR 52514; 81 FR 59266; 81 FR 60115; 81 FR
66722; 81 FR 68098; 81 FR 71173; 81 FR 72642; 81 FR 74494; 81 FR 80161;
81 FR 81230; 81 FR 90050; 81 FR 96196; 82 FR 20962; 82 FR 37499; 83 FR
18633; 83 FR

24585; 83 FR 28325; 83 FR 28332; 83 FR 28342; 83 FR 34661; 83 FR 34677;
83 FR 40638; 83 FR 45750; 83 FR 53724; 83 FR 56137; 83 FR 56902):
Rodney R. Anderson (PA)
Gary A. Brown (PA)
James W. Carter, Jr. (KS)
Jose D. Chavez (MD)
David M. Clark (MD)
David A. Coburn, Sr. (VT)
Thomas L. Corey (IN)
Herman A. Davis (AL)
Joseph A. Dunlap (OH)
Tyron O. Friese (MN)
Randy M. Garcia (NM)
Andeberhan O. Gidey (WA)
Rodney P. Hains (ND)
Ronnie L. Henry (KS)
William G. Hix (AR)
Daniel Hollins (KY)
Darryl D. Kelley (TX)
Timothy L. Klose (PA)
Aaron C. Lougher (OR)
Phillip E. Mason (MO)
Odilio Monterroso De Leon (TX)
Dennis E. Palmer, Jr. (CT)
Larry A. Priewe (ND)
Christopher W. Robinson (NY)
Scott D. Russell (WI)
Benjamin R. Sauder (PA)
Jimmy E. Settle (MO)
Mark A. Smith (IA)
Leon W. Tanksley (GA)
Brian C. Wittenburg (NC)
    The drivers were included in docket numbers FMCSA-1998-3637; FMCSA-
1999-6480; FMCSA-2000-7165; FMCSA-2000-8203; FMCSA-2002-12294; FMCSA-
2003-16564; FMCSA-2005-22194; FMCSA-2006-23773; FMCSA-2008-0266; FMCSA-
2009-0206; FMCSA-2009-0291; FMCSA-2010-0201; FMCSA-2011-0379; FMCSA-
2014-0002; FMCSA-2014-0004; FMCSA-2014-0006; FMCSA-2014-0007; FMCSA-
2014-0010; FMCSA-2016-0029; FMCSA-2016-0031; FMCSA-2016-0033; FMCSA-
2016-0206; FMCSA-2017-0017; FMCSA-2018-0010; FMCSA-2018-0011; FMCSA-
2018-0017. Their exemptions are applicable as of November 9, 2020, and
will expire on November 9, 2022.
    As of November 11, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following eight individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (81 FR 70248; 81 FR 70251; 81 FR
70253; 81 FR 90046; 81 FR 96178; 81 FR 96191; 83 FR 53724):
Elijah A. Allen (AR)
Daniel L. Bawden (IL)
Timothy J. Dougherty (MN)
Josh Gallant (SC)
Dillon L. Hendren (SC)
George P. Mendiola (CA)
Alfred L. Robinson (AR)
Jerry L. Smith (VA)
    The drivers were included in docket numbers FMCSA-2016-0207; FMCSA-
2016-0208; FMCSA-2016-0209. Their exemptions are applicable as of
November 11, 2020, and will expire on November 11, 2022.
    As of November 22, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following three individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (79 FR 63211; 80 FR 2471; 81 FR
72664; 81 FR 94013; 83 FR 53724):
    Peter J. Faber (NE); James F. McLaughlin (MN); and Michael J.
Monroe (IA)
    The drivers were included in docket numbers FMCSA-2014-0297; FMCSA-
2016-0210. Their exemptions are applicable as of November 22, 2020, and
will expire on November 22, 2022.
    As of November 24, 2020, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (83 FR 53727; 84 FR 2328):
    Marcel Spinu (WA)
    The driver was included in docket number FMCSA-2018-0018. The
exemption is applicable as of November 24, 2020, and will expire on
November 24, 2022.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must undergo an annual physical examination (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a certified medical examiner (ME), as defined by Sec.
390.5, who attests that the driver is otherwise physically qualified
under Sec.  391.41; (2) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the ME at the time of the
annual medical examination; and (3) each driver must provide a copy of
the annual medical certification to the employer for retention in the
driver's qualification file or keep a copy of his/her driver's
qualification if he/her is self-employed. The driver must also have a
copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official. The exemption
will be rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the 42 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the vision
requirement in Sec.  391.41(b)(10), subject to the requirements cited
above. In accordance with 49 U.S.C. 31136(e) and 31315(b), each
exemption will be valid for 2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-21898 Filed 10-2-20; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 15 (Tuesday, January 24, 2023)]
[Rules and Regulations]
[Pages 4086-4087]
[FR Doc No: 2023-01179]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 316

[Docket No. FDA-2011-N-0583]

Clarification of Orphan-Drug Exclusivity Following Catalyst
Pharms., Inc. v. Becerra; Notification

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Notification.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
this notification in light of the recent decision by the U.S. Court of
Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra.
The Catalyst decision addressed the orphan-drug exclusivity provision
of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by
the Orphan Drug Act and subsequent amendments, and concluded that FDA's
approval of Jacobus Pharmaceutical Company's (Jacobus's) drug (the drug
at issue in the litigation) must be set aside. Consistent with the
court's decision, FDA has set aside its approval of Jacobus's drug.
This notification announces that, at this time, while complying with
the court's order in Catalyst, FDA intends to continue to apply its
regulations tying the scope of orphan-drug exclusivity to the uses or
indications for which a drug is approved to matters beyond the scope of
that order.

DATES: The policy set out in this document is effective January 24,
2023.

FOR FURTHER INFORMATION CONTACT: Aaron Friedman, Office of Orphan
Products Development, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 30, 2021, the U.S. Court of Appeals for the Eleventh
Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra
(Catalyst), 14 F.4th 1299 (11th Cir. 2021).
    At the time of the litigation, Jacobus and Catalyst Pharmaceuticals
(Catalyst) each had orphan-drug designation for the drug amifampridine
for the treatment of Lambert-Eaton myasthenic syndrome (LEMS). In
November 2018, FDA approved Catalyst's drug for the treatment of LEMS
in adults. FDA recognized Catalyst's drug as eligible for orphan-drug
exclusivity for its only approved indication--the treatment of LEMS in
adults.
    In May 2019, FDA approved Jacobus's drug for the treatment of LEMS
in children. In approving Jacobus's drug, FDA followed its longstanding
rule, codified in its regulations, that the orphan-drug exclusivity for
Catalyst's drug protected only the approved use or indication within
the designated disease. See 21 CFR 316.3(b)(12), 316.31(a)-(b). The
regulation in 21 CFR 316.31(b) states, in part, that: ``Orphan-drug
exclusive approval protects only the approved indication or use of a
designated drug.'' \1\
---------------------------------------------------------------------------

    \1\ Emphasis added. Other regulatory provisions also reflect the
understanding that orphan-drug exclusivity is tied to the use or
indication for which the drug was approved. See Sec.  316.3(b)(12)
(stating that ``no approval will be given to a subsequent sponsor of
the same drug for the same use or indication for 7 years'' (emphasis
added)); see also id. Sec.  316.31(a) (explaining that FDA may
approve an orphan drug for ``select indication(s) or use(s) within
the rare disease or condition for which the drug was designated''
and that ``FDA will not approve another sponsor's marketing
application for the same drug for the same use or indication before
the expiration of 7 years from the date of such approval'' (emphases
added)).
---------------------------------------------------------------------------

    In June 2019, Catalyst filed suit against FDA, challenging FDA's
approval of Jacobus's application under the Administrative Procedure
Act, 5 U.S.C. 701-706. Among other things, Catalyst argued that the
phrase ``same disease or condition'' in the Orphan Drug Act, 21 U.S.C.
360cc(a), unambiguously prohibited FDA from approving Jacobus's drug
application. Specifically, Catalyst argued that the Orphan Drug Act
required orphan-drug exclusivity to extend to all uses or indications
within the orphan-designated disease or condition--even uses or
indications for which Catalyst had not received approval, such as the
treatment of LEMS in children.
    The district court rejected Catalyst's argument that the Orphan
Drug Act required orphan-drug exclusivity to apply to all uses or
indications within the orphan-designated disease or condition. The
district court concluded that, given the context and the overall
statutory scheme, the statute was ambiguous on the disputed issue, and
that FDA had reasonably interpreted the statute to tie orphan-drug
exclusivity to the uses or indications for which the drug was approved.
    On appeal, the U.S. Court of Appeals for the Eleventh Circuit
reversed. The circuit court concluded that the phrase ``same disease or
condition'' in the Orphan Drug Act, 21 U.S.C. 360cc(a), unambiguously
foreclosed FDA's interpretation of the provision. Accordingly, the
circuit court held that orphan-drug exclusivity for Catalyst's

drug blocked FDA's approval of Jacobus's drug for all uses or
indications within the orphan-designated disease (LEMS)--even though
Catalyst's drug was approved at that time only for use in the treatment
of LEMS in adults. The court concluded that FDA's approval of Jacobus's
drug for the treatment of LEMS in children must be set aside.
Consistent with the court's decision, the Agency set aside the approval
of Jacobus's drug.

II. Orphan-Drug Exclusivity

    The Agency is issuing this statement to address the uncertainty
created by the circuit court's decision in Catalyst. The court ordered
FDA to set aside its approval of Jacobus's drug, and FDA has set aside
that approval. This notification announces that, at this time, in
matters beyond the scope of that court order, FDA intends to continue
to apply its existing regulations tying orphan-drug exclusivity to the
uses or indications for which the orphan drug was approved. The Agency
believes that this approach is appropriate for several reasons. FDA
continues to believe that the statutory text does not unambiguously
require that orphan-drug exclusivity extend to the entire disease or
condition for which a drug received orphan-drug designation if the drug
is only approved for some uses within that disease or condition.
Further, FDA believes that its statutory interpretation embodied in its
regulations best advances the Orphan Drug Act's purposes, appropriately
balancing the need to incentivize the development of drugs for rare
diseases and conditions with the need to provide patient access to
orphan drugs. The regulations accomplish this by tying the scope of
orphan-drug exclusivity to only the approved use or indication of the
drug, which permits other sponsors to obtain approval of the drug for
uses or indications within the same orphan-designated disease or
condition that have not yet been approved (i.e., that are ``new'').
Under the regulations, a drug approved for a new use or indication
within the same orphan-designated disease or condition may also be
eligible for orphan-drug exclusivity for such use or indication. These
regulations incentivize sponsors to continue to develop a drug for use
in all persons affected by a rare disease or condition. Thus, FDA
believes that continued adherence to its validly promulgated
regulations will best serve the public health by facilitating patient
access to orphan drugs, especially for difficult-to-study patients such
as young children.

III. Conclusion

    For the above reasons, at this time, the Agency intends to continue
to apply its longstanding regulations tying the scope of orphan-drug
exclusivity to the uses or indications for which the orphan drug was
approved.

    Dated: January 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01179 Filed 1-23-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Rules and Regulations]
[Pages 48002-48006]
[FR Doc No: 2011-19898]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2011-0211; FRL-9446-6]

Approval and Promulgation of Air Quality Implementation Plans;
State of California; Interstate Transport of Pollution; Interference
With Prevention of Significant Deterioration Requirement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is finalizing a limited approval and limited disapproval
of a state implementation plan (SIP) revision submitted by the State of
California on November 17, 2007, to address the ``transport SIP''
provisions of Clean Air Act (CAA) section 110(a)(2)(D)(i) for the 1997
8-hour ozone National Ambient Air Quality Standards (NAAQS or
standards) and the 1997 fine particulate matter (PM2.5)
NAAQS. Section 110(a)(2)(D)(i) of the CAA requires that each SIP
contain, among other things, adequate measures prohibiting emissions of
air pollutants in amounts which will interfere with any other State's
measures required under title I, part C of the CAA to prevent
significant deterioration of air quality. EPA is approving California's
SIP revision with respect to those Districts that implement SIP-
approved permit programs meeting the approval criteria and
simultaneously disapproving California's SIP revision with respect to
those Districts that do not implement SIP-approved permit programs
meeting the approval criteria, as discussed in our May 31, 2011
proposed rule (76 FR 31263).

DATES: This final rule is effective September 7, 2011.

ADDRESSES: EPA has established a docket for this action under EPA-R09-
OAR-2011-0211. The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA
Region IX, 75 Hawthorne Street, San Francisco, California. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material) and some may not be available in either location (e.g.,
confidential business information (CBI)). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.
Although listed in the index, some information is not publicly
available, i.e., CBI or other information the disclosure of which 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.

FOR FURTHER INFORMATION CONTACT: Rory Mays, Air Planning Office (AIR-
2), U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we'',
``us'', and ``our'' refer to EPA.

I. Summary of the Proposed Actions

    On May 31, 2011 (76 FR 31263), EPA proposed a limited approval and
limited disapproval of a SIP revision submitted by the California Air
Resources Board (CARB) on November 17, 2007, to address the ``transport
SIP'' provisions of CAA section 110(a)(2)(D)(i) for the 1997 8-hour
ozone NAAQS and the 1997 PM2.5 NAAQS (2007 Transport SIP).
Specifically, EPA proposed a limited approval and limited disapproval
of the 2007 Transport SIP with respect to the requirement in CAA
section 110(a)(2)(D)(i)(II) that each SIP contain adequate measures
prohibiting emissions of air pollutants in amounts which will interfere
with any other State's measures required under title I, part C of the
CAA to prevent significant deterioration of air quality. We refer to
this requirement as ``element (3)'' of section 110(a)(2)(D)(i).

A. Proposed Action With Respect to 1997 8-Hour Ozone NAAQS

    We proposed the following actions with respect to element (3) of
CAA section 110(a)(2)(D)(i) for the 1997 8-hour ozone NAAQS. For nine
Districts \1\ that are designated nonattainment and classified under
subpart 2 of part D, title I of the CAA and that have SIP-approved
nonattainment area new source review (NNSR) programs meeting the
approval criteria discussed in our May 31, 2011 proposed rule, we
proposed to approve the 2007 Transport SIP.
---------------------------------------------------------------------------

    \1\ Antelope Valley Air Quality Management District (AQMD), Bay
Area AQMD, El Dorado County Air Pollution Control District (APCD),
Imperial County APCD, Mojave Desert AQMD, San Joaquin Valley APCD,
South Coast AQMD, Ventura County APCD, and Yolo-Solano AQMD.
---------------------------------------------------------------------------

    For three Districts \2\ with nonattainment areas classified under
subpart 2 for which NNSR SIP revisions were necessary to meet the
approval criteria, we proposed to approve the 2007 Transport SIP if we
finalized approval of the required NNSR SIP revisions by our July 10,
2011 Consent Decree deadline for final action on element (3) of the
2007 Transport SIP.\3\ Alternatively, for any of these Districts for
which we could not approve the required NNSR SIP revision by our July
10, 2011 deadline, we proposed to disapprove the 2007 Transport SIP
with respect to element (3) of CAA section 110(a)(2)(D)(i) for the 1997
8-hour ozone NAAQS and to promulgate a limited NNSR Federal
Implementation Plan (FIP) addressing the relevant requirements.
---------------------------------------------------------------------------

    \2\ Feather River AQMD, Placer County APCD, and Sacramento
Metropolitan AQMD.
    \3\ See WildEarth Guardians v. U.S. EPA (Case No. 4:09-CV-02453-
CW), Consent Decree dated November 10, 2009, as amended by Notice of
Stipulated Extensions to Consent Decree Deadlines, dated April 28,
2011 (establishing July 10, 2011 deadline for final action on
element (3) of the 2007 Transport SIP). The July 10, 2011 deadline
was further extended to July 29, 2011 by Notice of Stipulated
Extension to Consent Decree Deadlines, dated July 7, 2011.
---------------------------------------------------------------------------

    For two Districts \4\ with ``former subpart 1'' nonattainment areas
that implement SIP-approved NNSR programs meeting the approval
criteria,

we proposed to approve the 2007 Transport SIP.
---------------------------------------------------------------------------

    \4\ Eastern Kern APCD and San Diego County APCD.
---------------------------------------------------------------------------

    For seven Districts \5\ with ``former subpart 1'' nonattainment
areas that do not yet have SIP-approved NNSR programs, we proposed to
disapprove the 2007 Transport SIP but to determine that implementation
of the provisions of 40 CFR part 51, Appendix S (``The Interpretative
Rule'') \6\ during this interim period pending EPA's final subpart 2
classifications of these areas adequately addresses the requirements of
element (3) of CAA section 110(a)(2)(D)(i) and, therefore, discharges
EPA's obligation to promulgate a FIP for these limited purposes.
---------------------------------------------------------------------------

    \5\ Amador County APCD, Butte County AQMD, Calaveras County
APCD, Feather River AQMD, Mariposa County APCD, Northern Sierra
AQMD, and Tuolumne County APCD.
    \6\ Note that the waiver provisions in section VI of 40 CFR part
51 Appendix S no longer apply. See Phase 2 Rule, 75 FR 71612
(November 29, 2005) and NRDC v. EPA, 571 F. 3d 1245 (DC Cir. 2009)
(vacating EPA's elimination of the 18-month limitation in 40 CFR
part 52.24(k) with respect to the waiver provisions in section VI of
40 CFR part 51 Appendix S).
---------------------------------------------------------------------------

    For Monterey Bay Unified APCD (``Monterey''), which is designated
unclassifiable/attainment and has a SIP-approved Prevention of
Significant Deterioration (PSD) program meeting the approval criteria,
we proposed to approve the 2007 Transport SIP.
    For two Districts \7\ with unclassifiable/attainment areas for
which we recently approved PSD SIP revisions meeting the approval
criteria by direct final rule, we proposed to approve the 2007
Transport SIP. Alternatively, we proposed to disapprove the 2007
Transport SIP if either of these direct final rules were withdrawn and
would not become effective by our July 10, 2011 Consent Decree
deadline, in which case we would promulgate a limited PSD FIP for the
relevant District based on the provisions of 40 CFR 52.21 identifying
NOX as an ozone precursor.
---------------------------------------------------------------------------

    \7\ Mendocino County AQMD and Northern Sonoma County APCD.
---------------------------------------------------------------------------

    For North Coast Unified AQMD (``North Coast''), we proposed to
disapprove the 2007 Transport SIP and to promulgate a limited PSD FIP
for NOX emission sources only, as discussed in our May 31,
2011 proposed rule. By separate action published in today's Federal
Register, EPA finalized that limited PSD FIP for North Coast.\8\
---------------------------------------------------------------------------

    \8\ See fn. 3 above.
---------------------------------------------------------------------------

    For the rest of the State, which is designated unclassifiable/
attainment for the 1997 8-hour ozone NAAQS and subject to the Federal
PSD program in 40 CFR 52.21, we proposed to disapprove the 2007
Transport SIP but to determine that no further action is required to
address element (3) of CAA section 110(a)(2)(D)(i) because EPA has
already promulgated a PSD FIP for these areas.

B. Proposed Action With Respect to 1997 PM2.5 NAAQS

    We proposed the following actions with respect to element (3) of
CAA section 110(a)(2)(D)(i) for the 1997 PM2.5 NAAQS. For
two Districts \9\ that are designated nonattainment, we proposed to
approve the 2007 Transport SIP based on a determination that
implementation of The Interpretative Rule during the SIP-development
period adequately addresses the requirements of element (3) of CAA
section 110(a)(2)(D)(i).
---------------------------------------------------------------------------

    \9\ San Joaquin Valley APCD and the South Coast Air Basin
portion of South Coast AQMD.
---------------------------------------------------------------------------

    For five Districts \10\ that are designated unclassifiable/
attainment and that have SIP-approved PSD programs meeting the approval
criteria discussed above, we proposed to approve the 2007 Transport
SIP.
---------------------------------------------------------------------------

    \10\ Mendocino County AQMD, Monterey Bay Unified APCD, North
Coast Unified AQMD, Northern Sonoma County APCD, and Sacramento
Metropolitan AQMD.
---------------------------------------------------------------------------

    For the rest of the State, which is designated unclassifiable/
attainment and subject to the Federal PSD program in 40 CFR 52.21, we
proposed to disapprove the 2007 Transport SIP but to determine that no
further action is required to address element (3) of CAA section
110(a)(2)(D)(i) because EPA has already promulgated a PSD FIP for these
areas.

C. Proposed Action With Respect to Greenhouse Gases

    Finally, with respect to PSD authority to regulate greenhouse gases
(GHGs), we proposed to take the following actions. For three Districts
\11\ that were subject to the PSD SIP Narrowing Rule (75 FR 82536,
December 30, 2010), we proposed to fully approve the 2007 Transport SIP
with respect to element (3) of CAA section 110(a)(2)(D)(i) based on
letters from each District. These letters clarified that the 2007
Transport SIP should be read, with respect to CAA section
110(a)(2)(D)(i)(II), to reflect each of their PSD programs as they are
currently federally approved as a result of the PSD SIP Narrowing Rule.
---------------------------------------------------------------------------

    \11\ Mendocino County AQMD, Northern Sonoma County APCD, and
North Coast Unified AQMD. Note that footnote 24 of our proposed rule
(76 FR 31263 at 31268) incorrectly identifies Monterey Bay Unified
APCD instead of Northern Sonoma County APCD as one of the three
Districts that were subject to the PSD SIP Narrowing Rule but that
our Technical Support Document correctly identifies the relevant
Districts.
---------------------------------------------------------------------------

    For Monterey, which has confirmed that its SIP provides GHG PSD
permitting authority at thresholds consistent with the Tailoring Rule,
we proposed to fully approve the 2007 Transport SIP with respect to
element (3) of CAA section 110(a)(2)(D)(i).
    For Sacramento Metropolitan AQMD (``Sacramento''), which was
subject to the PSD GHG SIP Call (75 FR 77698, December 13, 2010), we
proposed to fully approve the 2007 Transport SIP with respect to
element (3) of CAA section 110(a)(2)(D)(i) if Sacramento's corrective
SIP revision to address GHG permitting requirements received EPA
approval.
    For all other areas in California, which are subject to the Federal
PSD program in 40 CFR 52.21, we proposed to disapprove the 2007
Transport SIP but to determine that no further action is required to
address element (3) of CAA section 110(a)(2)(D)(i) because EPA has
already promulgated a PSD FIP for these areas.
    For a more detailed explanation of our evaluation of the 2007
Transport SIP with respect to element (3) of CAA section
110(a)(2)(D)(i) and of the rationale for our proposed actions, please
see our May 31, 2011 proposed rule and related Technical Support
Document (76 FR 31263).

II. EPA's Response to Comments

    Our May 31, 2011 proposed rule provided for a 30-day comment
period. We did not receive any public comments in response to the
proposed rule.

III. Final Action

    Under sections 110(k)(3) and 301(a) of the CAA, EPA is finalizing a
limited approval and limited disapproval of the 2007 Transport SIP
submitted by CARB on November 17, 2007. We are finalizing a limited
approval and limited disapproval action because the 2007 Transport SIP
is not separable with respect to individual California Districts, and
because, although the submittal as a whole strengthens the SIP and
meets the applicable CAA requirements for certain Districts, it does
not meet the applicable requirements for certain other Districts, as
discussed in Section I of this final rule and in our May 31, 2011
proposed rule.
    Specifically, we are approving the 2007 Transport SIP as meeting
the requirements of element (3) of CAA section 110(a)(2)(D)(i) with
respect to the following areas:
     Twelve Districts \12\ that implement SIP-approved NNSR or
PSD programs

meeting the approval criteria for the 1997 8-hour ozone NAAQS;
---------------------------------------------------------------------------

    \12\ Antelope Valley AQMD, Bay Area AQMD, El Dorado County APCD,
Imperial County APCD, Mojave Desert AQMD, San Joaquin Valley APCD,
South Coast AQMD, Ventura County APCD, Yolo-Solano AQMD, Eastern
Kern APCD, San Diego County APCD, and Monterey Bay Unified APCD.
---------------------------------------------------------------------------

     Three Districts \13\ for which we have recently approved
the required NNSR SIP revisions for the 1997 8-hour ozone NAAQS (see 76
FR 43183, July 20, 2011 (Final rule, Sacramento Metropolitan AQMD NNSR
and PSD SIP revisions); and Final rule, ``Revisions to the California
State Implementation Plan, Placer County Air Pollution Control District
and Feather River Air Quality Management District,'' signed June 30,
2011);
---------------------------------------------------------------------------

    \13\ Feather River AQMD, Placer County APCD, and Sacramento
Metropolitan AQMD.
---------------------------------------------------------------------------

     Two Districts \14\ for which we have recently approved the
required PSD SIP revisions for the 1997 8-hour ozone NAAQS (see 76 FR
26192 (May 6, 2011));
---------------------------------------------------------------------------

    \14\ Mendocino County AQMD and Northern Sonoma County APCD.
---------------------------------------------------------------------------

     Five Districts \15\ that implement SIP-approved PSD
programs meeting the approval criteria for the 1997 PM2.5
NAAQS;
---------------------------------------------------------------------------

    \15\ Mendocino County AQMD, Monterey Bay Unified AQMD, North
Coast Unified AQMD, Northern Sonoma County APCD, and Sacramento
Metropolitan AQMD.
---------------------------------------------------------------------------

     Four Districts \16\ that implement SIP-approved PSD
programs meeting the approval criteria for greenhouse gases (GHGs); and
---------------------------------------------------------------------------

    \16\ Mendocino County AQMD, Monterey Bay Unified APCD, North
Coast Unified AQMD, and Northern Sonoma County APCD.
---------------------------------------------------------------------------

     One District (Sacramento) for which we have recently
approved the required PSD SIP revision for GHGs (see 76 FR 43183, July
20, 2011 (Final rule, Sacramento Metropolitan AQMD NNSR and PSD SIP
revisions)).
    We are simultaneously disapproving the 2007 Transport SIP for
failure to meet the requirements of element (3) of CAA section
110(a)(2)(D)(i) with respect to the following areas:
     Seven Districts \17\ with ``former subpart 1'' ozone
nonattainment areas that do not yet have SIP-approved NNSR programs
meeting the approval criteria for the 1997 8-hour ozone NAAQS;
---------------------------------------------------------------------------

    \17\ Amador County APCD, Butte County AQMD, Calaveras County
APCD, Feather River AQMD, Northern Sierra AQMD, Mariposa County
APCD, and Tuolumne County APCD.
---------------------------------------------------------------------------

     One District (North Coast) for which EPA has not yet
approved a PSD SIP revision meeting the approval criteria for the 1997
8-hour ozone NAAQS; and
     All areas in the State that are subject to the Federal PSD
program in 40 CFR 52.21 for the 1997 8-hour ozone NAAQS, the 1997
PM2.5 NAAQS, and/or GHGs, where the California SIP remains
deficient with respect to PSD requirements.
    Under section 179(a) of the CAA, final disapproval of a submittal
that addresses a requirement of part D, title I of the CAA (CAA
sections 171-193) or is required in response to a finding of
substantial inadequacy as described in CAA section 110(k)(5) (SIP Call)
starts a sanctions clock. The 2007 Transport SIP was not submitted to
meet either of these requirements. Therefore, this final limited
disapproval does not trigger a sanctions clock.
    Disapproval of a required SIP revision also triggers the
requirement under CAA section 110(c) that EPA promulgate a FIP no later
than 2 years from the date of the disapproval unless the State corrects
the deficiency, and the Administrator approves the plan or plan
revision before the Administrator promulgates such FIP. For the seven
Districts with ``former subpart 1'' ozone nonattainment areas for which
we are disapproving the 2007 Transport SIP (because they do not yet
have SIP-approved NNSR programs meeting the approval criteria for the
1997 8-hour ozone NAAQS), we are finalizing our proposal to conclude
that current implementation of The Interpretative Rule in these areas
adequately addresses the requirements of element (3) of CAA section
110(a)(2)(D)(i) for the 1997 8-hour ozone NAAQS and, therefore,
discharges EPA's obligation to promulgate a FIP for these limited
purposes.
    For all other Districts for which we are disapproving the 2007
Transport SIP, with the exception of North Coast, EPA has already
incorporated into the applicable SIP the provisions of the Federal PSD
program contained in 40 CFR 52.21 and, therefore, has no further
obligation to promulgate a FIP to address the requirements of element
(3) of CAA section 110(a)(2)(D)(i).
    With respect to North Coast, which implements a PSD program that
does not currently satisfy element (3) of CAA section 110(a)(2)(D)(i)
for the 1997 8-hour ozone NAAQS, by separate action published in
today's Federal Register, EPA finalized a limited PSD FIP, as discussed
herein and in our May 31, 2011 proposed rule. That limited PSD FIP will
apply only until EPA approves the required PSD SIP revision for this
area.\18\
---------------------------------------------------------------------------

    \18\ We note that CARB submitted a PSD SIP revision for North
Coast Unified AQMD on February 28, 2011 to address, among other
things, the requirement to identify NOX as an ozone
precursor.
---------------------------------------------------------------------------

    Finally, with respect to the five Districts \19\ for which NNSR or
PSD SIP revisions were necessary to meet the transport SIP approval
criteria for the 1997 8-hour ozone NAAQS, we are not finalizing the
limited NNSR/PSD FIPs that we had proposed in the alternative to codify
in 40 CFR sections 52.233, 52.270(b)(3)(iv), and 52.270(b)(4)(iv). We
are approving the 2007 Transport SIP for these Districts based on our
final approval of the required SIP revisions, as discussed in Section I
of this final rule and in our May 31, 2011 proposed rule.
---------------------------------------------------------------------------

    \19\ Feather River AQMD, Placer County APCD, Sacramento
Metropolitan AQMD, Mendocino County AQMD, and Northern Sonoma County
APCD.
---------------------------------------------------------------------------

IV. Statutory and Executive Order Reviews

A. Executive Order 12866, Regulatory Planning and Review

    The Office of Management and Budget (OMB) has exempted this
regulatory action from Executive Order 12866, entitled ``Regulatory
Planning and Review.''

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to conduct a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements unless the agency certifies
that the rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small not-for-profit enterprises, and small governmental
jurisdictions.
    This rule will not have a significant impact on a substantial
number of small entities because SIP approvals and limited approvals/
limited disapprovals under section 110 and subchapter I, part D of the
Clean Air Act do not create any new requirements but simply approve
requirements that the State is already imposing. Therefore, because
this limited approval/limited disapproval action does not create any
new requirements, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
    Moreover, due to the nature of the Federal-State relationship under
the Clean Air Act, preparation of flexibility analysis would constitute
Federal

inquiry into the economic reasonableness of State action. The Clean Air
Act forbids EPA to base its actions concerning SIPs on such grounds.
Union Electric Co., v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C.
7410(a)(2).

D. Unfunded Mandates Reform Act

    Under section 202 of the Unfunded Mandates Reform Act of 1995
(``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA
must prepare a budgetary impact statement to accompany any proposed or
final rule that includes a Federal mandate that may result in estimated
costs to State, local, or tribal governments in the aggregate; or to
the private sector, of $100 million or more. Under section 205, EPA
must select the most cost-effective and least burdensome alternative
that achieves the objectives of the rule and is consistent with
statutory requirements. Section 203 requires EPA to establish a plan
for informing and advising any small governments that may be
significantly or uniquely impacted by the rule.
    EPA has determined that the limited approval/limited disapproval
action promulgated today does not include a Federal mandate that may
result in estimated costs of $100 million or more to either State,
local, or tribal governments in the aggregate, or to the private
sector. This Federal action approves pre-existing requirements under
State or local law, and imposes no new requirements. Accordingly, no
additional costs to State, local, or tribal governments, or to the
private sector, result from this action.

E. Executive Order 13132, Federalism

    Federalism (64 FR 43255, August 10, 1999) revokes and replaces
Executive Orders 12612 (Federalism) and 12875 (Enhancing the
Intergovernmental Partnership). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' Under Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the proposed regulation. EPA also may not issue a regulation
that has federalism implications and that preempts State law unless the
Agency consults with State and local officials early in the process of
developing the proposed regulation.
    This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132, because it
merely approves in part and disapproves in part a State plan
implementing a Federal requirement, and does not alter the relationship
or the distribution of power and responsibilities established in the
Clean Air Act. Thus, the requirements of section 6 of the Executive
Order do not apply to this rule.

F. Executive Order 13175, Coordination With Indian Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' This rule does not have
tribal implications, as specified in Executive Order 13175. It will not
have substantial direct effects on tribal governments, on the
relationship between the Federal government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 does not
apply to this rule.

G. Executive Order 13045, Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying only to those regulatory actions that concern health or
safety risks, such that the analysis required under section 5-501 of
the Executive Order has the potential to influence the regulation. This
rule is not subject to Executive Order 13045, because it approves in
part and disapproves in part a State plan implementing a Federal
requirement.

H. Executive Order 13211, Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211, ``Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use'' (66 FR 28355, May 22, 2001) because it is not a
significant regulatory action under Executive Order 12866.

 I. National Technology Transfer and Advancement Act

    Section 12 of the National Technology Transfer and Advancement Act
(NTTAA) of 1995 requires Federal agencies to evaluate existing
technical standards when developing a new regulation. To comply with
NTTAA, EPA must consider and use ``voluntary consensus standards''
(VCS) if available and applicable when developing programs and policies
unless doing so would be inconsistent with applicable law or otherwise
impractical.
    The EPA believes that VCS are inapplicable to this action. Today's
action does not require the public to perform activities conducive to
the use of VCS.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, Feb. 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA lacks the discretionary authority to address environmental
justice in this rulemaking.

K. Congressional Review Act

    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 rule 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

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).

L. Petitions for Review of This Action

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 7, 2011. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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 in 40 CFR Part 52

    Air pollution control, Incorporation by reference,
Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping requirements, and Volatile organic
compounds.

    Dated: July 25, 2011.
Keith Takata,
Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

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

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

0
2. Section 52.220 is amended by paragraph (c)(386)(ii)(A)(4) to read as
follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (386) * * *
    (ii) * * *
    (A) * * *
    (4) 2007 Transport SIP at pages 21-22 (Attachment A) (``Evaluation
of interference with Prevention of Significant Deterioration Measures
of any other State'').
* * * * *

0
3. Section 52.283 is amended by adding paragraph (a)(3) to read as
follows:

Sec.  52.283  Interstate Transport.

    (a) * * * (3) The requirements of section 110(a)(2)(D)(i)(II)
regarding interference with any other state's measures required under
title I, part C of the Clean Air Act to prevent significant
deterioration of air quality, except that these requirements are not
fully met in the Air Pollution Control Districts (APCDs) or Air Quality
Management Districts (AQMDs) listed in ths paragraph.

(i) Amador County APCD
(ii) Butte County AQMD
(iii) Calaveras County APCD
(iv) Feather River AQMD
(v) Northern Sierra AQMD
(vi) Mariposa County APCD
(vii) Tuolumne County APCD
(viii) North Coast Unified AQMD
(ix) All other areas in California that are subject to the Federal PSD
program as provided in 40 CFR 52.270.
* * * * *
[FR Doc. 2011-19898 Filed 8-5-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 18 (Friday, January 27, 2023)]
[Notices]
[Page 5331]
[FR Doc No: 2023-01663]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project Nos. 10675-021, 10676-027, 10677-024, and 10678-026]

Central Rivers Power MA, LLC; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC)
regulations, 18 Code of Federal Regulations (CFR) part 380, Commission
staff reviewed Central Rivers Power MA, LLC's application to amend the
terms and conditions for the exemptions from licensing for the Dwight
Project No. 10675, Red Bridge Project No. 10676, Putts Bridge Project
No. 10677, and Indian Orchard Project No. 10678 and have prepared an
Environmental Assessment (EA). The U.S. Fish and Wildlife Service and
the Massachusetts Division of Fish and Wildlife have provided updated
terms and conditions for the exemptions that modify operation of the
projects. Primarily the updated terms and conditions stipulate
operation of the projects in a run-of-river mode, with revised bypass
flow releases. The projects are located on the Chicopee River in
Hampden County, Massachusetts, and do not occupy federal lands.
    The EA contains Commission staff's analysis of the potential
environmental effects of the proposed amendment, and concludes that it
would not constitute a major federal action that would significantly
affect the quality of the human environment.
    The Commission provides all interested persons with an opportunity
to view and/or print the EA via the internet through the Commission's
Home Page (http://www.ferc.gov) using the ``eLibrary'' link. Enter the
docket number, excluding the last three digits in the docket number
field, to access the document. For assistance, contact FERC Online
Support at [email protected] or toll-free at<PHONE_NUMBER>,
or for TTY,<PHONE_NUMBER>.
    You may also register online at https://ferconline.ferc.gov/eSubscription.aspx to be notified via email of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 30 days from the date of this
notice. The Commission strongly encourages electronic filing. Please
file comments using the Commission's eFiling system at https://ferconline.ferc.gov/eFiling.aspx. Commenters can submit brief comments
up to 6,000 characters, without prior registration, using the eComment
system at https://ferconline.ferc.gov/QuickComment.aspx. You must
include your name and contact information at the end of your comments.
For assistance, please contact FERC Online Support. In lieu of
electronic filings, you may submit a paper copy. Submissions sent via
the U.S. Postal Service must be addressed to: Kimberly D. Bose,
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Room 1A, Washington, DC 20426. The first page of any filing should
include docket numbers P-10675-021, P-10676-027, P-10677-024, and P-
10678-026.
    For further information, contact Rebecca Martin at<PHONE_NUMBER> or
[email protected].

    Dated: January 23, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-01663 Filed 1-26-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13339-13341]
[FR Doc No: 2013-04531]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9785-2; EPA-R01-OEP-FRL: 13-007]

State Program Requirements; Approval of Maine's National
Pollutant Discharge Elimination System (NPDES) Permitting Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice. Proposal To Approve Maine's National Pollutant
Discharge Elimination System (NPDES) Permitting Program.

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SUMMARY: In 1999 the State of Maine applied to implement its NPDES
program under the Clean Water Act in the state, including the
territories of the Aroostook Band of Micmacs and the Houlton Band of
Maliseet Indians. Today, EPA is proposing to act on the state's
application as it applies in those Indian territories and is inviting
comment.

DATES: Interested persons may submit comments on the approval of
Maine's NPDES Permitting Program in these territories as part of the
administrative record to EPA--Region 1, at the address given below, no
later than midnight through April 29, 2013.

ADDRESSES: Submit comments by one of the following methods:
     Email<EMAIL_ADDRESS>     Mail: Glenda V[eacute]lez, USEPA-Region 1, 5 Post Office
Square--OEP06-01, Boston, MA 02109-3912.
     No facsimiles (faxes) will be accepted.

FOR FURTHER INFORMATION: Additional information concerning the proposed
approval of Maine's program in these territories may be obtained
between the hours of 9 a.m. and 5 p.m. Monday through Friday excluding
holidays from: Glenda V[eacute]lez, USEPA-Region 1, 5 Post Office
Square-OEP06-01, Boston, MA 02109-3912, Telephone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

2001 Approval of Maine's Base NPDES Permitting Program

    On December 17, 1999, EPA determined that the State of Maine had
submitted a complete application to administer the National Pollutant
Discharge Elimination System (NPDES) permitting program in the state
under the Clean Water Act (CWA). 33 U.S.C. 1251, et seq., see 64 FR
73552 (Dec. 30, 1999). Maine's application included an assertion of
authority to implement the program in the territories of the federally-
recognized Indian tribes within the state, based on the jurisdictional
provisions of the Maine Indian Claims Settlement Act (MICSA), which
ratified the Maine Implementing Act (MIA). 25 U.S.C. 1721, et seq. and
30 M.R.S.A. Sec.  6201, et seq., respectively.
    On January 12, 2001, EPA approved the State of Maine's application
to administer the NPDES program for all areas of the state other than
Indian country. At that point EPA did not take any action on Maine's
application to administer the program within the territories of the
federally-recognized Indian tribes in Maine. EPA published notice of
its action on February 28, 2001. 56 FR 12791. As described in the
Federal Register, EPA approved the state's application to administer
both the NPDES permit program covering point source dischargers and the
pretreatment program covering industrial dischargers into publicly
owned treatment works (POTWs). EPA did not authorize the state to
regulate cooling water intake structures under CWA section 316(b) (33
U.S.C. 1326(b)). 56 FR at 12792.

2003 Partial Approval of Maine's Program in Indian Territories

    On October 31, 2003, EPA approved the State of Maine's application
to administer the NPDES program in the

Indian territories of the Penobscot Indian Nation and the Passamaquoddy
Tribe, with the exception of any discharges that qualified as
``internal tribal matters'' under MICSA and MIA. 68 FR 65052 (Nov. 18,
2003). This action generally authorized the state to administer the
NPDES program in the territories of the two largest Indian tribes in
the state, finding that the combination of MICSA and MIA created a
unique jurisdictional arrangement that granted the state authority to
issue permits to dischargers. EPA did not approve the state's program
to regulate two small tribally-owned and operated POTWs. EPA determined
that permitting these POTWs qualified as an internal tribal matter and,
therefore, fell within an enumerated exception to the grant of
jurisdiction to the state in MICSA and MIA. EPA also did not take
action on the state's application as it applied to the territories of
the two other federally-recognized tribes in the state, the Houlton
Band of Maliseet Indians and the Aroostook Band of Micmacs. These two
tribes are subject to jurisdictional provisions different from those
that apply to the Penobscot and Passamaquoddy tribes.

2012 Approval of Maine's Program as to Penobscot and Passamaquoddy
Tribal Discharges

    On March 26, 2012, EPA approved Maine's NPDES program to apply to
tribally owned and operated discharges in the territories of the
Penobscot Nation and Passamaquoddy Tribe (the ``southern tribes''),
pursuant to the decision of the Federal Court of Appeals for the First
Circuit. 77 FR 23481 (April 19, 2012). The court had found that such
discharges did not qualify as internal tribal matters and were,
therefore, subject to the laws of the state. Maine v. Johnson. 498 F.3d
37 (1st Cir. 2007). As a result, EPA approved the state to implement
its program in the territories of the southern tribes without
exception. Accordingly, the state assumed responsibility from EPA for
issuing and administering the two permits EPA had previously withheld
for the Penobscot Nation Indian Island treatment works (EPA NPDES
Permit No. ME 0101311 and MEPDES License No. 2672) and the
Passamaquoddy Tribal Council treatment works (EPA NPDES Permit No.
1011773 and MEPDES License No. 2561). In that action the EPA only
approved the state's program with respect to the two permits for the
two tribal treatment works. EPA did not take action on Maine's program
application with respect to the Aroostook Band of Micmacs and Houlton
Band of Maliseet Indians (the ``northern tribes'').

Intervening Legal Developments

    In the process leading up to EPA's 2003 partial approval of the
state's program in Indian country, EPA had invited comment on the
state's jurisdiction under MICSA to implement its program in the
territories of all the Indian tribes in Maine, including the northern
tribes. Since EPA's initial decision to defer action on the state's
application as it applies to the northern tribes, the Federal Court of
Appeals for the First Circuit has issued several opinions which clarify
the operation of MICSA's jurisdictional provisions as they apply to
those tribes. Therefore, EPA is again inviting comment on Maine's
application to administer its program in the northern tribes'
territories so that interested parties can address those opinions and
any other aspects of Maine's NPDES program relevant to authorizing the
state's NPDES program in these tribes' territories. In this way, EPA
can respond to comments that more accurately reflect the current state
of the law and program implementation, rather than comments from 2000
and 2001.
    In brief, there are three decisions from the First Circuit that EPA
expects will guide the Agency's analysis of the jurisdictional issues
in acting on Maine's application as it applies to the northern tribes.
The first is Maine v. Johnson. 498 F.3d 37. As described above, the
court held that MICSA's ``internal tribal matters'' exception to the
state's jurisdiction over the southern tribes did not include
discharges of pollutants into navigable waters to be permitted under
Maine's program. Id. at 46. Therefore, Maine's state permitting program
applies without exception in the territories of the southern tribes,
and the state has jurisdiction sufficient for EPA to approve the
state's program under the federal Clean Water Act.
    Second, in Aroostook Band of Micmacs v. Ryan, 484 F.3d 41 (2007)
the court held that MICSA made the Aroostook Band subject to the
state's jurisdiction without the exception for ``internal tribal
matters'' that is available to the southern tribes. Id. at 50. Third,
in Houlton Band of Maliseet Indians v. Ryan the court extended this
analysis to the Maliseet tribe. 484 F.3d 73, 74-75 (1st Cir. 2007). In
both these cases, each tribe sought to block enforcement of Maine's
antidiscrimination laws in connection with the tribes' decision to
terminate the employment of certain tribal government employees. The
court held that the tribes were subject to state regulation when making
such employment decisions.

Proposed Action on Maine's Program

    Employment decisions by tribal governments qualify as an internal
tribal matter with respect to the southern tribes and, therefore, are
beyond the reach of state regulation under MICSA. Penobscot Nation v.
Fellencer, 164 F.3d 706 (1st Cir. 1999). In its pair of decisions in
2007, the First Circuit clarified that the scope of Maine's
jurisdictional authority over the northern tribes reaches further than
the state's authority over the southern tribes, and the state can
regulate matters of the northern tribes that would qualify as internal
tribal matters of the southern tribes. The First Circuit has ruled that
the state has adequate authority to implement its NPDES program in the
territories of the southern tribes, even in the face of the internal
tribal matters exception the southern tribes have from state
regulation. It appears to follow, therefore, that Maine has an even
stronger claim of authority to implement its NPDES program in the
territories of the northern tribes.
    Accordingly, EPA proposes to approve the state to implement its
NPDES program in the territories of the Houlton Band of Maliseet
Indians and the Aroostook Band of Micmacs, provided Maine submits and
EPA approves a program addressing the requirements of CWA section
316(b) as described below. EPA invites comment on both the
determination of the state's jurisdiction to implement the program in
these tribes' territories and the respective roles of the state,
tribes, and EPA in the context of a state implementing the NPDES
program in the territories of federally recognized tribes in Maine.\1\
---------------------------------------------------------------------------

    \1\ Neither tribe has applied to EPA to implement the NPDES
permit program, so this proposed action does not invite comment on
the question of whether either tribe has authority to implement the
program.
---------------------------------------------------------------------------

    Note that in 2001 when EPA first approved the state's program,
Maine did not have authority to regulate cooling water intake
structures under CWA section 316(b). The state has since granted Maine
DEP that authority, and EPA is working with DEP to develop the state
regulations necessary for Maine to implement that program. Once Maine
submits that program, EPA will publish a separate notice inviting
comment on the adequacy of Maine's section 316(b) program before taking
final action to approve the state's NPDES program, including the
section 316(b) program, in these territories. The Agency is inviting
comment now on the balance of the

---------------------------------------------------------------------------
state's permitting program and the jurisdictional issue.

    Authority:  This action is proposed to be taken under the
authority of Section 402 of the Clean Water Act as amended, 42
U.S.C. 1342.

    Dated: January 31, 2013.
H. Curtis Spalding,
Regional Administrator, Region 1.
[FR Doc. 2013-04531 Filed 2-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 22, 2009 (Volume 74, Number 76)]
[Notices]
[Page 18409]
[DOCID:fr22ap09-80]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213

Extension:
    Rule 15g-3, OMB Control No. 3235-0392, SEC File No. 270-346.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget a request for approval of extension of the existing
collection of information provided for in the following rule: Rule 15g-
3--Broker or dealer disclosure of quotations and other information
relating to the penny stock market (17 CFR 240.15g-3) under the
Securities Exchange Act of 1934 (15 U.S.C. 78a et seq.).
    Rule 15g-3 requires that brokers and dealers disclose to customers
current quotation prices or similar market information in connection
with transactions in penny stocks. The purpose of the rule is to
increase the level of disclosure to investors concerning penny stocks
generally and specific penny stock transactions.
    The Commission estimates that approximately 240 broker-dealers will
each spend an average of 100 hours annually to comply with the rule.
Thus, the total compliance burden is estimated to be approximately
24,000 burden-hours per year.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Comments should be directed to: (i) Desk Officer for the Securities
and Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503 or by sending an e-mail to: Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Shirley Martinson,
6432 General Green Way, Alexandria, VA 22312 or send an e-mail to PRA_
<EMAIL_ADDRESS>Comments must be submitted within 30 days of this
notice.

    Dated: April 15, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-9160 Filed 4-21-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 25 (Wednesday, February 6, 2019)]
[Notices]
[Page 2208]
[FR Doc No: 2019-01149]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-55-000]

Notice of Request Under Blanket Authorization: Southern Natural
Gas Company, LLC

    Take notice that on January 22, 2019, Southern Natural Gas Company,
LLC (Southern) 569 Brookwood Village, Suite 749, Birmingham, Alabama
35209, filed in Docket No. CP19-55-000 a prior notice request pursuant
to sections 157.205 and 157.210 of the Commission's regulations under
the Natural Gas Act (NGA), and Southern's blanket certificate issued in
Docket No. CP82-406-000, seeking authorization to replace a tap and
suction line tied to its North Main System in order to increase
capacity (North Main Upgrade Project). Southern states that as a result
of Southern's open season posted on September 18, 2018, the shipper
Southern Company Services, Inc. amended their Service Agreement with
Southern to provide an additional 5,000 dekatherm per day of firm
transportation on Southern's North Main System. Southern determined
that operational capacity is available on a short term basis at this
location, however, additional facilities will be required to provide
this service throughout the term of the agreement.
    Specifically, Southern proposes to replace the 12-inch tap and
suction line located at its McConnells Compressor Station with a 20-
inch tap and suction line. This tap and suction line connects to
Southern's 22-inch North Main System at Milepost 260.742 in Tuscaloosa
County, Alabama. This proposed tap and suction line replacement will
take place entirely within the footprint of Southern's property located
at its McConnells Compressor Station. The North Main Upgrade Project
will increase the efficiency of Southern's North Main System without
the need for additional compression or pipeline looping. Southern
estimates the cost of the Project to be $1.7 million, all as more fully
set forth in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to T.
Brooks Henderson, Director, Rates & Regulatory Affairs Department, PO
Box 2563, Birmingham, Alabama 35202-2563, by telephone at (205)325-
3843, or by email at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the EA for this proposal. The filing of the EA in the Commission's
public record for this proceeding or the issuance of a Notice of
Schedule for Environmental Review will serve to notify federal and
state agencies of the timing for the completion of all necessary
reviews, and the subsequent need to complete all federal authorizations
within 90 days of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.

    Dated: January 30, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-01149 Filed 2-5-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Page 42820]
[FR Doc No: 2021-16730]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-260]

Alabama Power Company; Notice of Application Accepted for Filing
and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Non-Capacity Amendment of License.
    b. Project No: P-2146-260.
    c. Date Filed: July 2, 2021.
    d. Applicant: Alabama Power Company (Alabama Power).
    e. Name of Project: Coosa River Project.
    f. Location: The project is located on the Coosa River, in Coosa,
Chilton, Talladega and Shelby counties, Alabama.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Alan L. Peeples, Alabama Power Company, 600
North 18th Street, P.O. Box 2641, Birmingham, AL 35291-8180, (205) 257-
1401.
    i. FERC Contact: Zeena Aljibury,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance date of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests, comments, or recommendations using the
Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include the docket
number P-2146-260. Comments emailed to Commission staff are not
considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervenor files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency
    k. Description of Request: Alabama Power requests approval to
modify Unit 6 at the Lay Development to address significant maintenance
needs and to improve power and efficiency. The proposed scope of work
for Unit 6 includes complete turbine replacement, wicket gate
replacement, wicket gate stem bushings installation, turbine, and
generator bearing upgrades, and related component replacement. Alabama
Power states the turbine replacement is not expected to result in an
increase to the total rated capacity or the maximum discharge of the
unit at rated conditions. Alabama Power notes that project operations
will not change, and refurbishment will not include any structural
changes to the project facilities.
    l. Locations of the Application: The Commission provides all
interested persons an opportunity to view and/or print the contents of
this document via the internet through the Commission's website at
http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number
excluding the last three digits in the docket number field to access
the document. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and
issuances related to this or other pending projects. Agencies may
obtain copies of the application directly from the applicant. At this
time, the Commission has suspended access to the Commission's Public
Reference Room due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll free,
(866) 208-3676 or TTY,<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214, respectively. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: July 30, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-16730 Filed 8-4-21; 8:45 am]
BILLING CODE 6717-01-P