[Federal Register: June 1, 2010 (Volume 75, Number 104)]
[Notices]
[Page 30390-30391]
[DOCID:fr01jn10-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

May 21, 2010.
    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER08-394-026.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc.
submits proposed revisions to its Open Access Transmission, Energy and
Operating Reserves Markets Tariff etc.
    Filed Date: 05/20/2010.
    Accession Number: 20100521-0202.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 10, 2010.

    Docket Numbers: ER10-1106-001.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35: Correction to PG&E's GMC Baseline Filing to be effective 4/28/
2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5062.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1283-000.
    Applicants: Southern California Edison Company.
    Description: Southern California Edison submits a revised rate
sheet reflecting the cancellation of a letter agreement with the City
of Pasadena.
    Filed Date: 05/20/2010.
    Accession Number: 20100520-0211.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 10, 2010.

    Docket Numbers: ER10-1284-000.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas and Electric Company submits changes in
their transmission revenue requirement and rate revisions related to
changes to Post-Employment Benefits Other Than pensions expense levels.
    Filed Date: 05/20/2010.
    Accession Number: 20100520-0210.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 10, 2010.

    Docket Numbers: ER10-1285-000.
    Applicants: Craven County Wood Energy Limited Partnership.
    Description: Craven County Wood Energy Limited Partnership submits
tariff filing per 35.12: Craven County Wood Energy LP FERC Schedule No.
1 Electric Tariff to be effective 5/24/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5016.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1286-000.
    Applicants: Portland General Electric Company.
    Description: Portland General Electric Company submits a second
amendment to its Electric Rate Schedule FERC No. 78 et al.
    Filed Date: 05/20/2010.
    Accession Number: 20100521-0201.
    Comment Date: 5 p.m. Eastern Time on Thursday, June 10, 2010.

    Docket Numbers: ER10-1287-000.
    Applicants: Grayling Generation Station Limited Partnership.
    Description: Grayling Generation Station Limited Partnership
submits tariff filing per 35.12: Grayling Generating Station LP FERC
Schedule No. 1 Electric Tariff to be effective 5/24/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5020.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.

    Docket Numbers: ER10-1288-000.
    Applicants: Exeter Energy Limited Partnership.
    Description: Exeter Energy Limited Partnership submits tariff
filing per 35.12: Exeter Energy Limited Partnership (``Exeter'') FERC
Schedule No. 1 Electric Tariff to be effective 5/24/2010.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5037.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.
    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES10-43-000.
    Applicants: El Paso Electric Company.
    Description: Application of El Paso Electric Company for
Authorization under Section 204 of the FPA.
    Filed Date: 05/19/2010.
    Accession Number: 20100519-5126.
    Comment Date: 5 p.m. Eastern Time on Wednesday, June 09, 2010.

    Docket Numbers: ES10-44-000.
    Applicants: Orange and Rockland Utilities, Inc.
    Description: Application Pursuant to Section 204 of Orange and
Rockland Utilities, Inc. for Authority to Issue and Sell Short Term
Debt.
    Filed Date: 05/21/2010.
    Accession Number: 20100521-5045.
    Comment Date: 5 p.m. Eastern Time on Friday, June 11, 2010.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. 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. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    As it relates to any qualifying facility filings, the notices of
self-certification [or self-recertification] listed above, do not
institute a proceeding regarding qualifying facility status. A notice
of self-certification [or self-recertification] simply provides
notification that the entity making the filing has determined the
facility named in the notice meets the applicable criteria to be a
qualifying facility. Intervention and/or protest do not lie in dockets
that are qualifying facility self-certifications or self-
recertifications. Any person seeking to challenge such qualifying
facility status may do so by filing a motion pursuant to 18 CFR
292.207(d)(iii). Intervention and protests may be filed in response to
notices of qualifying facility dockets other than self-certifications
and self-recertifications.
    The Commission encourages electronic submission of protests and

interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St, NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-12984 Filed 5-28-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43271-43272]
[FR Doc No: 2013-17279]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Applications for
Modification of Special Permit

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before August 5, 2013.
    Address Comments To: Record Center, Pipeline and Hazardous
Materials Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue Southeast, Washington DC or at http://regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR
1.53(b)).

    Issued in Washington DC, on July 15, 2013.
Donald Burger,
Chief, General Approvals and Permits.

----------------------------------------------------------------------------------------------------------------
                                                                         Regulation(s)       Nature of special
Application No.     Docket No.                 Applicant                    affected          permit thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
11352-M........  ...............  PepsiCo, Inc. Arlington, TX........  49 CFR 172.200;    To modify the special
                                                                        172.300;           permit to authorize
                                                                        172.400; 172.500   additional Class 3,
                                                                                8, and 9 materials.
11947-M........  ...............  Patts Fabrication, Inc. Midland, TX  49 CFR 173.202;    To modify the special
                                                                        173.203;           permit to authorize
                                                                        173.241; 173.242   additional Class 3
                                                                                and 8 materials.
13133-M........  ...............  Department of Defense Scott AFB, IL  49 CFR 172.320;    To modify the special
                                                                        173.54(a);         permit to remove the
                                                                        173.56(b);         requirement that new
                                                                        173.57; 173.58;    explosive substances
                                                                        173.62             must be tested and
                                                                                pass the UN Test
                                                                                Series 3 tests.

15110-M........  ...............  Kidde Technologies, Inc., dba Kidde  49 CFR 178.65....  To modify the special
                                   Aerospace & Defense Wilson, NC.                         permit to authorize
                                                                                minor dimensional
                                                                                changes for the
                                                                                existing
                                                                                developmental drawing
                                                                                348711 which is part
                                                                                of weldment design
                                                                                447235, the addition
                                                                                of two new weldment
                                                                                designs, two
                                                                                additional Division
                                                                                2.2 materials, and
                                                                                the use of these
                                                                                cylinders as
                                                                                components on US
                                                                                Naval Aircraft.
15634-M........  ...............  SodaStream USA Mount Laurel, NJ....  49 CFR 171.2(k)..  To modify the special
                                                                                permit to authorize
                                                                                the transportation of
                                                                                cylinders by motor
                                                                                vehicle consistent
                                                                                with the limited
                                                                                quanitiy exception.
15691-M........  ...............  Department of Defense Scotts AFB,    49 CFR 180.209...  To reissue the special
                                   IL.                                                     permit originally
                                                                                issued on an
                                                                                emergency basis.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-17279 Filed 7-18-13; 8:45 am]
BILLING CODE 4909-60-P


[Federal Register Volume 80, Number 152 (Friday, August 7, 2015)]
[Notices]
[Pages 47550-47552]
[FR Doc No: 2015-19383]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-31732]

Notice of Applications for Deregistration Under Section 8(f) of
the Investment Company Act of 1940

July 31, 2015.
    The following is a notice of applications for deregistration under
section 8(f) of the Investment Company Act of 1940 for the month of
July 2015. A copy of each application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the Company name box, at http://www.sec.gov/search/search.htm or by calling<PHONE_NUMBER>. An order granting each
application will be issued unless the SEC orders a hearing. Interested
persons may request a hearing on any application by writing to the
SEC's Secretary at the address below and serving the relevant applicant
with a copy of the request, personally or by mail. Hearing requests
should be received by the SEC by 5:30 p.m. on August 25, 2015, and
should be accompanied by proof of service on applicants, in the form of
an affidavit or, for lawyers, a certificate of service. Pursuant to
Rule 0-5 under the Act, hearing requests should state the nature of the
writer's interest, any facts bearing upon the desirability of a hearing
on the matter, the reason for the request, and the issues contested.
Persons who wish to be notified of a hearing may request notification
by writing to the Commission's Secretary.

ADDRESSES: The Commission: Brent J. Fields, Secretary, U.S. Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.

FOR FURTHER INFORMATION CONTACT: Diane L. Titus at<PHONE_NUMBER>, SEC,
Division of Investment Management, Chief Counsel's Office, 100 F Street
NE., Washington, DC 20549-8010.

Dow 30 Premium & Dividend Income Fund Inc. [File No. 811-21708]

Dow 30 Enhanced Premium & Income Fund Inc. [File No. 811-22029]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen Dow 30sm Dynamic
Overwrite Fund, and on December 22, 2014, made distributions to their
shareholders based on net asset value. Expenses of $536,640 incurred in
connection with the reorganization were paid by applicants.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Encompass Funds [File No. 811-21885]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On May 29, 2015, applicant made a liquidating
distribution to its shareholders, based on net asset value. Expenses of
$14,433 incurred in connection with the liquidation were paid by Brick
Asset Management, Inc., applicant's investment adviser.
    Filing Date: The application was filed on July 17, 2015.
    Applicant's Address: 1700 California St., Ste. 335, San Francisco,
CA 94109.

KKR Series Trust [File No. 811-22720]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. On March 31, 2014, applicant made a
liquidating distribution to its shareholders, based on net asset value.
Expenses in connection with the liquidation were paid by KKR Credit
Advisors (US) LLC, applicant's investment adviser.
    Filing Date: The application was filed on July 17, 2015.
    Applicant's Address: 555 California St., 50th Floor, San Francisco,
CA 94104.

BlackRock MuniYield New Jersey Quality Fund, Inc. [File No. 811-7138]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant
transferred its assets to BlackRock MuniHoldings New Jersey Quality
Fund, Inc. on July 13, 2015. Expenses of $310,020 incurred in
connection with the reorganization were paid by applicant and BlackRock
Advisors, LLC, applicant's investment adviser.
    Filing Date: The application was filed on July 9, 2015.
    Applicant's Address: 100 Bellevue Parkway, Wilmington, DE 19809.

John Hancock Tax-Exempt Series Fund [File No. 811-5079]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant transferred its assets to John
Hancock Tax-Free Bond Fund, a series of John Hancock Municipal
Securities Trust, and on February 13, 2015, made distributions to its
shareholders based on net asset value. Expenses of $201,891 incurred in
connection with the reorganization were paid by applicant and John
Hancock Advisers, LLC, applicant's investment adviser.

    Filing Date: The application was filed on July 7, 2015.
    Applicant's Address: 601 Congress St., Boston, MA 02210-2805.

ACP Strategic Opportunities Fund II LLC [File No. 811-21031]

ACP Funds Trust [File No. 811-21324]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company. On May
21, 2015, applicants made their final liquidating distributions to
their shareholders, based on net asset value. Applicants incurred no
expenses in connection with the liquidations.
    Filing Date: The applications were filed on July 17, 2015.
    Applicants' Address: Ascendant Capital Partners LP, C/O Barlow
Partners, 880 Third Ave., 3rd Floor, New York, NY 10022.

Nuveen Massachusetts Dividend Advantage Municipal Fund [File No. 811-
9451]

Nuveen Massachusetts AMT-Free Municipal Income Fund [File No. 811-
21216]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen Massachusetts Premium
Income Municipal Fund, and on June 9, 2014, made distributions to their
shareholders based on net asset value. Expenses of approximately
$497,000 incurred in connection with reorganizations were paid by
applicants and the acquiring fund.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Nuveen Global Income Opportunities Fund [File No. 811-21893]

Nuveen Diversified Currency Opportunities Fund [File No. 811-22018]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen Global High Income Fund,
and on November 24, 2014, made distributions to their shareholders
based on net asset value. Expenses of $763,852 incurred in connection
with the reorganizations were paid by applicants.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Nuveen Equity Premium Advantage Fund [File No. 811-21731]

NASDAQ Premium Income & Growth Fund Inc. [File No. 811-21983]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen NASDAQ 100 Dynamic
Overwrite Fund, and on December 22, 2014, made distributions to their
shareholders based on net asset value. Expenses of $528,102 incurred in
connection with the reorganizations were paid by applicants.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Nuveen New Jersey Investment Quality Municipal Fund Inc. [File No. 811-
6264]

Nuveen New Jersey Premium Income Municipal Fund Inc. [File No. 811-
7118]

Nuveen New Jersey Dividend Advantage Municipal Fund 2 [File No. 811-
10551]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen New Jersey Dividend
Advantage Municipal Fund, and on November 10, 2014, made distributions
to their shareholders based on net asset value. Expenses of
approximately $1,242,000 incurred in connection with the
reorganizations were paid by applicants, the acquiring fund and Nuveen
Fund Advisors, LLC, applicants' investment adviser.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Nuveen Pennsylvania Premium Income Municipal Fund 2 [File No. 811-7482]

Nuveen Pennsylvania Dividend Advantage Municipal Fund [File No. 811-
9457]

Nuveen Pennsylvania Dividend Advantage Municipal Fund 2 [File No. 811-
10549]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen Pennsylvania Investment
Quality Municipal Fund, and on February 10, 2014, transferred their
assets to their shareholders based on net asset value. Expenses of
approximately $1,166,000 incurred in connection with the reorganization
were paid by applicants and the acquiring fund.
    Filing Date: The applications were filed on June 26, 2015.
    Applicants' Address: 333 West Wacker Dr., Chicago, IL 60606.

Nuveen California Performance Plus Municipal Fund Inc. [File No. 811-
5930]

Nuveen California Municipal Market Opportunity Fund Inc. [File No. 811-
6081]

Nuveen California Investment Quality Municipal Fund Inc. [File No. 811-
6177]

Nuveen California Select Quality Municipal Fund Inc. [File No. 811-
6294]

Nuveen California Quality Income Municipal Fund Inc. [File No. 811-
6425]

    Summary: Each applicant, a closed-end investment company, seeks an
order declaring that it has ceased to be an investment company.
Applicants transferred their assets to Nuveen California Dividend
Advantage Municipal Fund, and on June 9, 2014, made distributions to
their shareholders based on net asset value. Expenses of $1,931,348
incurred in connection with the reorganizations were paid by applicants
and the acquiring fund.
    Filing Date: The applications were filed on June 26, 2015.
    Applicant's Address: 333 West Wacker Dr., Chicago, IL 60606.

Putnam Limited Duration Government Income Fund [File No. 811-6257]

    Summary: Applicant seeks an order declaring that it has ceased to
be an investment company. Applicant transferred its assets to Putnam
U.S. Government Income Trust, and on November 12, 2007, made
distributions to its shareholders based on net asset value. Expenses of
approximately $324,064 incurred in connection with the reorganization
were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on July 22, 2015.
    Applicant's Address: One Post Office Square, Boston, MA 02109.

Cantor Opportunistic Alternatives Fund, LLC [File No. 811-21943]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. On March 29,
2015, applicant made a liquidating distribution to its shareholders,
based on net asset value. Expenses of $2,625

incurred in connection with the liquidation were paid by Cantor
Fitzgerald Investment Advisors, L.P., applicant's investment adviser.
    Filing Dates: The application was filed on April 23, 2015, and
amended on July 22, 2015.
    Applicant's Address: 110 East 59th St., New York, NY 10022.

Sentry Variable Account I [File No. 811-3901]

    Summary: Applicant, a unit investment trust, seeks an order
declaring that it has ceased to be an investment company. On April 17,
2015, applicant made a final liquidating distribution to its unit
holders, based on net asset value. Applicant incurred no expenses in
connection with the liquidation.
    Filing Dates: The application was filed on June 16, 2015, and
amended on July 16, 2015.
    Applicant's Address: 220 Salina Meadows Parkway, Suite 255,
Syracuse, NY 13212.

Nuveen California Premium Income Municipal Fund [File No. 811-7720]

    Summary: Applicant, a closed-end investment company, seeks an order
declaring that it has ceased to be an investment company. Applicant
transferred its assets to Nuveen California AMT-Free Municipal Income
Fund, and on June 9, 2014, made a distribution to its shareholders
based on net asset value. Expenses of $589,639 incurred in connection
with the reorganization were paid by applicant and the acquiring fund.
    Filing Date: The application was filed on June 26, 2015.
    Applicant's Address: 333 West Wacker Dr., Chicago, IL 60606.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-19383 Filed 8-6-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 3, 2008 (Volume 73, Number 233)]
[Notices]
[Page 73659-73660]
[DOCID:fr03de08-35]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0609]

Draft Guidance for Industry on the Submission of Patent
Information for Certain Old Antibiotics; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Submission of
Patent Information for Certain Old Antibiotics.'' The draft guidance
describes the agency's current thinking on the implementation of
certain provisions of the Q1 Program Supplemental Funding Act (the Q1
Act) that concern old antibiotics and addresses which sponsors of new
drug applications (NDAs) must submit patent information under the Q1
Act by December 5, 2008.

DATES:  Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by February 2, 2009.

ADDRESSES:  Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT: Mary Ann Holovac, Center for Drug
Evaluation and Research (HFD-615), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Submission of Patent Information for Certain Old
Antibiotics.'' The draft guidance provides information regarding FDA's
current thinking on the implementation of section 4(b)(1) of the Q1 Act
(Public Law 110-379).
    The Q1 Act amends section 505 of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 355) by adding subsection (v),
which establishes, among other things, certain conditions under which
the patent listing, patent certification, and marketing exclusivity
provisions of sections 505(c) and (j) of the FD&C Act, and the patent
term extension provisions of 35 U.S.C. 156 apply to marketing
applications for drugs that contain an antibiotic that was the subject
of any marketing application received by FDA on or before November 20,
1997 (an old antibiotic). The transitional rules at section 4(b) of the
Q1 Act provide for the submission of the patent information by sponsors
of certain NDAs, the publication of such patent information by FDA, and
the certification to such patents by applicants of pending abbreviated
new drug applications to be deemed ``a first applicant'' (as defined in
section 505(j)(5)(B)(iv) the FD&C Act), not later than 60, 90, and 120
days after enactment of the Q1 Act, respectively.
    Specifically, section 4(b)(1) of the Q1 Act requires the submission
to FDA of patent information by sponsors of certain NDAs for drugs
(including

combination drugs) containing old antibiotics by December 5, 2008.\1\
The draft guidance describes FDA's current thinking on the
implementation of section 4(b)(1) of the Q1 Act and addresses which
sponsors of NDAs must submit patent information to the agency under
section 4(b)(1) of the Q1 Act by December 5, 2008.
---------------------------------------------------------------------------

    \1\ Section 4(b)(1) of the Q1 Act requires the submission of
patent information to FDA ``not later than sixty days after
enactment of [the Q1 Act].'' Sixty days after enactment falls on
Sunday, December 7, 2008. Therefore, to be in compliance with this
provision, sponsors must submit the patent information on or before
the weekday preceding December 7, 2008, that is, on or before
December 5, 2008.
---------------------------------------------------------------------------

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
submission of patent information under section 4(b)(1) of the Q1 Act.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.50(h) and 314.53 have been
approved under OMB control number 0910-0513.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: November 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28657 Filed 12-2-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 110 (Friday, June 9, 2017)]
[Rules and Regulations]
[Pages 26754-26757]
[FR Doc No: 2017-11900]

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

40 CFR Part 52

[EPA-R06-OAR-2014-0497; FRL-9962-47-Region 6]

Approval and Promulgation of Implementation Plans; Texas Control
of Air Pollution From Motor Vehicles With Mobile Source Incentive
Programs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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

SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving revisions to the
Texas State Implementation Plan (SIP) submitted by the State of Texas
that pertain to regulations to control air pollution from motor
vehicles with mobile source incentive programs.

DATES: This rule is effective on September 7, 2017 without further
notice, unless the EPA receives relevant adverse comment by July 10,
2017. If the EPA receives such comment, the EPA will publish a timely
withdrawal in the Federal Register informing the public that this rule
will not take effect.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2014-0497, at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>Follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the Web, cloud, or other file sharing system). For
additional submission methods, please contact Mr. Randy Pitre, (214)
665-

7299<EMAIL_ADDRESS>For the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at EPA Region 6,
1445 Ross Avenue, Suite 700, Dallas, Texas. 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 publicly available at either location (e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Mr. Randy Pitre,<PHONE_NUMBER>,
<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Mr. Randy Pitre or Mr. Bill Deese at 214-
665-7253.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

A. CAA and SIPs

    Section 110 of the CAA requires states to develop and submit to the
EPA a SIP to ensure that state air quality meets National Ambient Air
Quality Standards. These ambient standards currently address six
criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead,
particulate matter, and sulfur dioxide. Each federally-approved SIP
protects air quality primarily by addressing air pollution at its point
of origin through air pollution regulations and control strategies. The
EPA approved SIP regulations and control strategies are federally
enforceable.

B. Texas' Submittals

    Revisions with changes, additions, and extensions to the Texas SIP
Mobile Source Incentive Programs found in Title 30 of the Texas
Administrative Code (30 TAC), Chapter 114, (Control of Air Pollution
from Motor Vehicles), Subchapter K (Mobile Source Incentive Programs)
were submitted by the Texas Commission on Environmental Quality (TCEQ)
on June 11, 2014, December 23, 2014, and September 15, 2016. The June
11, 2014 submittal (1) revised regulations for the Diesel Emissions
Reduction Incentive Program for On-Road and Non-Road Vehicles (Division
3) and the Texas Clean Fleet Program (Division 5), and (2) added
regulations for a new Drayage Truck Incentive Program (Division 8). The
December 23, 2014 submittal revised the Texas Clean School Bus Program
(Division 4) to reflect the extension of this program by the Texas
Legislature. The September 15, 2016 submittal amended the Drayage Truck
Incentive Program regulations that were submitted on June 11, 2014.

II. The EPA's Evaluation

    We have prepared a Technical Support Document (TSD) for this
rulemaking which details our evaluation. Our TSD may be accessed online
at http://www.regulations.gov, Docket No. EPA-R06-OAR-2014-0497.
Because the SIP revisions pertain to economic incentive programs to
reduce air pollution emissions from mobile sources we evaluated them
using (1) CAA section 182(g) (Economic Incentive Program) (2) our
policy guidance on economic incentive programs found in 40 CFR part 51,
subpart U (Economic Incentive Programs) and (3) our guidance document
``Improving Air Quality with Economic Incentive Programs'' (EPA-452/R-
01-001, January 2001, www.epa.gov/sites/production/files/2015-07/documents/eipfin.pdf). An economic incentive program achieves an air
quality objective by providing market-based incentives or information
to emission sources. Three fundamental principles apply to all
approvable economic incentive programs: Integrity, equity, and
environmental benefit. Our analysis concluded that the SIP revisions to
the Texas mobile source incentive programs meet these principles and
are approvable. The Mobile Source Economic Incentive Programs are
consistent with the CAA as they will reduce air pollution and emissions
of NOX, which is a precursor to ozone and particulate
matter. The emission reductions from replacing vehicles or replacing,
repowering or retrofitting engines can be quantified, and provide an
environmental benefit by reducing air pollution emissions by
encouraging the use of newer diesel technologies in the Texas
nonattainment areas. If Texas includes emission reductions from these
programs in future attainment or reasonable further progress SIPs, EPA
will evaluate the amount of reductions it achieves at that time. We are
approving the Texas SIP submittals as part of the Texas SIP. A short
discussion of the programs is discussed below. For more information,
please see the TSD.

A. Diesel Emissions Reduction Incentive Program for On-Road and Non-
Road Vehicles

    The revisions to this program revise 30 TAC Sections 114.622 and
114.629. The revisions (1) remove the maximum cost-effectiveness limit
of $15,000 per ton of emissions of nitrogen oxides (NOX)
reduced for a project, (2) allow TCEQ to set cost-effectiveness limits
for projects and (3) add Wise County to the list of counties eligible
for the program.\1\ Removing the maximum cost-effectiveness limit and
allowing TCEQ to set the limits allows for selection of eligible
projects to improve air quality, even if the cost-effectiveness
increases above $15,000 per ton of NOX. Including Wise
County in the program ensures that all the Dallas-Fort Worth ozone
nonattainment counties are in the program.
---------------------------------------------------------------------------

    \1\ Wise County was included in the Dallas-Fort Worth ozone
nonattainment area for the 2008 ozone national ambient air quality
standard (77 FR 30088, 30147, May 21, 2012).
---------------------------------------------------------------------------

B. Texas Clean School Bus Program

    The revisions to this program revise 30 TAC Sections 114.640,
114.642, 114.644, 114.646 and 114.648 by repealing and replacing
existing provisions and revising 30 TAC Section 114.648 to clarify that
the Texas Legislature had extended the program until August 31, 2019.
Previously 30 TAC 114.648 stated that the program expired on August 31,
2013, unless the program is extended or reauthorized by the Texas
Legislature. Other than the clarification of the current program
expiration date, the revisions did not change the EPA approved SIP
provisions for this program.

C. Texas Clean Fleet Program

    The revisions to this program revise 30 TAC Sections 114.650,
114.653 and 114.656. The revisions allow certain projects related to
agricultural product transportation (i.e., projects for trucks that
move goods from a farm), to be eligible for the program to replace
older heavy-duty on-road vehicles. The revisions also include a new
maximum grant amount for replacement of a heavy-duty on-road vehicle or
a light-duty on-road vehicle with a grant of up to 80% of the
replacement vehicle.

D. Drayage Truck Incentive Program

    Drayage refers to the transport of goods over a short distance.
This program provides financial incentives to encourage owners to
replace drayage trucks with pre-2007 model engines with drayage trucks
with 2010 or later model year engines. The intent is to reduce
emissions from heavy-duty on-road and non-road vehicles used for
drayage activities through a seaport or rail yard.

III. Final Action

    We are approving revisions to the Texas SIP that pertain to
regulations to control air pollution from motor

vehicles with mobile source incentive programs. The revisions were
submitted on June 11, 2014, December 23, 2014 and September 15, 2016.
The revisions revise regulations for (1) the Diesel Emissions Reduction
Incentive Program for On-Road and Non-Road Vehicles (30 TAC Sections
114.622 and 114.629), (2) the Texas Clean School Bus Program (30 TAC
Sections 114.640, 114.642, 114.644, 114.646 and 114.648), and (3) the
Texas Clean Fleet Program (30 TAC Sections 114.650, 114.653 and
114.656). The revisions also add regulations for Drayage Truck
Incentive Program (30 TAC Sections 114.680, 114.681 and 114.682), and
the amendments to 30 TAC Sections 114.680 and 114.682.
    The EPA is publishing this rule without prior proposal because we
view this as a non-controversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the SIP revision if relevant adverse
comments are received. This rule will be effective on September 7, 2017
without further notice unless we receive relevant adverse comment by
July 10, 2017. If we receive relevant adverse comments, we will publish
a timely withdrawal in the Federal Register informing the public that
the rule will not take effect. We will address all public comments in a
subsequent final rule based on the proposed rule. We will not institute
a second comment period on this action. Any parties interested in
commenting must do so now. Please note that if we receive relevant
adverse comment on an amendment, paragraph, or section of this rule and
if that provision may be severed from the remainder of the rule, we may
adopt as final those provisions of the rule that are not the subject of
an adverse comment.

IV. Incorporation by Reference

    In this rule, we are finalizing regulatory text that includes
incorporation by reference. In accordance with the requirements of 1
CFR 51.5, we are finalizing the incorporation by reference of the
revisions to the Texas regulations as described in the Final Action
section above. We have made, and will continue to make, these documents
generally available electronically through www.regulations.gov and/or
in hard copy at the EPA Region 6 office.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the 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);
     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. The 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 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 August 8, 2017. 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).)
    Samuel Coleman was designated the Acting Regional Administrator on
May 30, 2017 through the order of succession outlined in Regional Order
R6-1110.13, a copy of which is included in the docket for this action.

List of Subjects in 40 CFR Part 52

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

    Dated: May 30, 2017.
Samuel Coleman,
Acting Regional Administrator, Region 6.

0
40 CFR part 52 is 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.

Subpart SS--Texas

0
2. In Sec.  52.2270(c), the table titled ``EPA Approved Regulations in
the Texas SIP'' is amended by:
0
a. Revising the centered heading for Chapter 114, Subchapter K,
Division 3

and the entries for sections 114.622, 114.629, 114.640, 114.642,
114.644, 114.646, 114.648, 114.650, 114.653, and 114.656; and
0
b. Adding, after the entry for section 114.658, the centered heading
for ``Division 8: Drayage Truck Incentive Program'' followed by entries
for sections 114.680, 114.681, and 114.682.
    The revisions and additions read as follows:

Sec.  52.2270   Identification of plan.

* * * * *
    (c) * * *

                                    EPA Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                     State approval/
        State citation             Title/subject        submittal     EPA approval date         Explanation
                                                          date
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                        Chapter 114 (Reg 4)--Control of Air Pollution from Motor Vehicles
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Subchapter K--Mobile Source Incentive Programs
----------------------------------------------------------------------------------------------------------------
           Division 3: Diesel Emissions Reduction Incentive Program for On-Road and Non-Road Vehicles
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Section 114.622...............  Incentive Program          4/9/2014  6/9/2017, [Insert    ......................
                                 Requirements.                        Federal Register
                                                                      citation].

                                                  * * * * * * *
Section 114.629...............  Affected Counties          4/9/2014  6/9/2017, [Insert    ......................
                                 and Implementation                   Federal Register
                                 Schedule.                            citation].
----------------------------------------------------------------------------------------------------------------
                                   Division 4: Texas Clean School Bus Program
----------------------------------------------------------------------------------------------------------------
Section 114.640...............  Definitions........       3/26/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].
Section 114.642...............  Applicability......       3/26/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].
Section 114.644...............  Clean School Bus          3/26/2014  6/9/2017, [Insert    ......................
                                 Program                              Federal Register
                                 Requirements.                        citation].
Section 114.646...............  Monitoring,               3/26/2014  6/9/2017, [Insert    ......................
                                 Recordkeeping, and                   Federal Register
                                 Reporting                            citation].
                                 Requirements.
Section 114.648...............  Expiration.........       3/26/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].
----------------------------------------------------------------------------------------------------------------
                                      Division 5: Texas Clean Fleet Program
----------------------------------------------------------------------------------------------------------------
Section 114.650...............  Definitions........        4/9/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].

                                                  * * * * * * *
Section 114.653...............  Grant Eligibility..        4/9/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].

                                                  * * * * * * *
Section 114.656...............  Eligible Grant             4/9/2014  6/9/2017, [Insert    ......................
                                 Amounts.                             Federal Register
                                                                      citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Division 8: Drayage Truck Incentive Program
----------------------------------------------------------------------------------------------------------------
Section 114.680...............  Definitions........        8/3/2016  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].
Section 114.681...............  Applicability......        4/9/2014  6/9/2017, [Insert    ......................
                                                                      Federal Register
                                                                      citation].
Section 114.682...............  Eligible Vehicle           8/3/2016  6/9/2017, [Insert    ......................
                                 Models.                              Federal Register
                                                                      citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-11900 Filed 6-8-17; 8:45 am]
 BILLING CODE 6560-50-P