[Federal Register Volume 78, Number 42 (Monday, March 4, 2013)]
[Notices]
[Pages 14095-14096]
[FR Doc No: 2013-04827]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-P-1071]

Determination That GEREF (Sermorelin Acetate) Injection, 0.5
Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF
(Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
GEREF (Sermorelin Acetate)

injection, 0.5 milligrams (mg) base/vial and 1.0 mg base/vial, and
GEREF (Sermorelin Acetate) injection, 0.05 mg base/amp, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, if all other legal and regulatory
requirements are met.

FOR FURTHER INFORMATION CONTACT:  Kathy Schreier, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave. Bldg. 51, Rm. 6252, Silver Spring, MD 20993-0002, 301-
796-3432.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA). The only clinical data
required in an ANDA are data to show that the drug that is the subject
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg
base/vial, is the subject of NDA 20-443, held by EMD Serono, and
initially approved on September 26, 1997; and GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp, is the subject of NDA 19-863,
held by EMD Serono, and initially approved on December 28, 1990. GEREF
(Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial,
is indicated for the treatment of idiopathic growth hormone deficiency
(GHD) in children with growth failure, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, is indicated for evaluating the ability of
the somatotroph of the pituitary gland to secrete growth hormone.
    In a letter dated December 2, 2008, EMD Serono notified FDA that
GEREF (Sermorelin Acetate) injection, 0.5 mg base/vial and 1.0 mg base/
vial, was being discontinued and requested withdrawal of NDA 20-443;
and FDA moved that drug product to the ``Discontinued Drug Product
List'' section of the Orange Book. In a letter dated July 11, 2008, EMD
Serono also notified FDA that GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book as well. In addition, in a letter dated December 12, 2008, EMD
Serono requested withdrawal of NDA 19-863 for GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp. In the Federal Register of May
19, 2009 (74 FR 23407), FDA announced that it was withdrawing approval
of NDA 19-863 and NDA 20-443, effective June 18, 2009.
    Alvin J. Lorman submitted a citizen petition dated October 12, 2012
(Docket No. FDA-2012-P-1071), under 21 CFR 10.30, requesting that the
Agency determine whether GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, was withdrawn from the market for
reasons of safety and efficacy. Although the citizen petition did not
request that we determine whether GEREF (Sermorelin Acetate) injection,
0.05 mg base/amp, approved under NDA 19-863, was withdrawn for safety
or efficacy, that product has also been discontinued. On our own
initiative, we have also determined whether GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, was withdrawn for safety or effectiveness
reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that GEREF (Sermorelin Acetate) injection, 0.5 mg
base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, were not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that GEREF (Sermorelin Acetate) injection, 0.5
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of GEREF (Sermorelin Acetate) injection, 0.5
mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin Acetate)
injection, 0.05 mg base/amp, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events for both GEREF products. We have reviewed the available
evidence and determined that both GEREF products were not withdrawn
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list GEREF (Sermorelin
Acetate) injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF
(Sermorelin Acetate) injection, 0.05 mg base/amp, in the ``Discontinued
Drug Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. ANDAs that refer to GEREF (Sermorelin Acetate)
injection, 0.5 mg base/vial and 1.0 mg base/vial, and GEREF (Sermorelin
Acetate) injection, 0.05 mg base/amp, may be approved by the Agency as
long as they meet all other legal and regulatory requirements for the
approval of ANDAs. If FDA determines that labeling for this drug
product should be revised to meet current standards, the Agency will
advise ANDA applicants to submit such labeling.

    Dated: February 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04827 Filed 3-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 16 (Tuesday, January 26, 2016)]
[Rules and Regulations]
[Pages 4175-4177]
[FR Doc No: 2016-00878]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31052; Amdt. No. 3674]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective January 26, 2016. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of January 26, 2016.

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

For Examination

    1. U.S. Department of Transportation, Docket Ops–M30, 1200
New

Jersey Avenue SE., West Bldg., Ground Floor, Washington, DC, 20590-
0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, call
202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

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

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Procedures
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK. 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR Sec.
97.20. The large number of SIAPs, their complex nature, and the need
for a special format make their verbatim publication in the Federal
Register expensive and impractical. Further, airmen do not use the
regulatory text of the SIAPs, but refer to their graphic depiction on
charts printed by publishers of aeronautical materials. Thus, the
advantages of incorporation by reference are realized and publication
of the complete description of each SIAP contained on FAA form
documents is unnecessary.
    This amendment provides the affected CFRs, and specifies the SIAPs
and Takeoff Minimums and ODPs with their applicable effective dates.
This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

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

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore-- (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR part 97

    Air traffic control, Airports, Incorporation by reference,
Navigation (air).

    Issued in Washington, DC on December 4, 2015.
John Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40106, 40113,
40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.31, 97.33, 97.35  [Amended]

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

* * * Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
                                                                           FDC
      AIRAC date          State           City             Airport        number     FDC date        Subject
----------------------------------------------------------------------------------------------------------------
7-Jan-16.............  WA           Everett.........  Snohomish County     5/4281      11/2/15  This NOTAM,
                                                       (Paine Fld).                              published in TL
                                                                                16-01, is
                                                                                hereby
                                                                                rescinded in
                                                                                its entirety.
7-Jan-16.............  DC           Washington......  Washington           5/0756     11/24/15  ILS OR LOC/DME
                                                       Dulles Intl.                              RWY 12, Amdt
                                                                                9A.
7-Jan-16.............  DC           Washington......  Washington           5/0758     11/24/15  ILS OR LOC/DME
                                                       Dulles Intl.                              RWY 1C, Amdt
                                                                                2B.
7-Jan-16.............  DC           Washington......  Washington           5/0764     11/24/15  VOR/DME RWY 12,
                                                       Dulles Intl.                              Amdt 9B.
7-Jan-16.............  DC           Washington......  Washington           5/0765     11/24/15  RNAV (GPS) RWY
                                                       Dulles Intl.                              12, Amdt 1A.
7-Jan-16.............  DC           Washington......  Washington           5/0766     11/24/15  RNAV (GPS) Y RWY
                                                       Dulles Intl.                              1C, Amdt 1A.
7-Jan-16.............  TN           Smithville......  Smithville Muni.     5/2872     11/23/15  RNAV (GPS) RWY
                                                                                6, Amdt 3.
7-Jan-16.............  TN           Smithville......  Smithville Muni.     5/2873     11/23/15  RNAV (GPS) RWY
                                                                                24, Amdt 3.
7-Jan-16.............  VA           Lynchburg.......  Lynchburg Rgnl/      5/4424     11/23/15  RNAV (GPS) RWY
                                                       Preston Glenn                             4, Orig.
                                                       Fld.
7-Jan-16.............  VA           Lynchburg.......  Lynchburg Rgnl/      5/4425     11/23/15  VOR RWY 4, Amdt
                                                       Preston Glenn                             12.
                                                       Fld.
7-Jan-16.............  VA           Lynchburg.......  Lynchburg Rgnl/      5/4426     11/23/15  RNAV (GPS) RWY
                                                       Preston Glenn                             22, Orig.
                                                       Fld.
7-Jan-16.............  VA           Lynchburg.......  Lynchburg Rgnl/      5/4427     11/23/15  VOR/DME RWY 22,
                                                       Preston Glenn                             Amdt 8B.
                                                       Fld.
7-Jan-16.............  VA           Lynchburg.......  Lynchburg Rgnl/      5/4428     11/23/15  ILS OR LOC RWY
                                                       Preston Glenn                             4, Amdt 17.
                                                       Fld.
7-Jan-16.............  SC           Charleston......  Charleston           5/8027     11/25/15  Takeoff Minimums
                                                       Executive.                                and (Obstacle)
                                                                                DP, Amdt 1.
7-Jan-16.............  GA           Macon...........  Middle Georgia       5/8992     11/24/15  RNAV (GPS) RWY
                                                       Rgnl.                                     5, Amdt 1B.
7-Jan-16.............  GA           Macon...........  Middle Georgia       5/8994     11/24/15  ILS OR LOC/DME
                                                       Rgnl.                                     RWY 5, Amdt 1B.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-00878 Filed 1-25-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80310-80312]
[FR Doc No: 2023-25458]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0053]

Notifying the Food and Drug Administration of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the Federal Food, Drug, and Cosmetic Act; Final
Guidance for Industry and Food and Drug Administration Staff; and
Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the final guidance entitled ``Notifying FDA of a
Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act'' and the draft guidance entitled
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act)
requires manufacturers to notify FDA of a permanent discontinuance or
an interruption in the manufacture of certain devices that is likely to
lead to a meaningful disruption in supply of that device in the United
States during or in advance of a public health emergency (PHE). This
final guidance is intended to assist manufacturers in providing timely,
informative notifications about changes in the production of certain
medical device products that will help prevent or mitigate shortages of
such devices. FDA is concurrently issuing a draft guidance to propose
select updates to the final guidance ``Notifying FDA of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the FD&C Act.'' This draft guidance proposes a list of
device product codes for which a manufacturer of such devices is
required to notify FDA in accordance with the FD&C Act (hereafter
referred to as the ``506J Device List'') and clarifies that
manufacturers may submit voluntary notifications regarding supply chain
issues at any time, unrelated to the declaration or potential
declaration of a PHE. This draft guidance is not final nor is it for
implementation at this time.

DATES: Submit either electronic or written comments on the draft
guidance by February 15, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0053 for ``Notifying FDA of a Permanent Discontinuance or
Interruption in Manufacturing of a Device Under Section 506J of the
FD&C Act'' or ``Select Updates for the 506J Guidance: 506J Device List
and Additional Notifications.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the final guidance document entitled
``Notifying FDA of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act'' or draft
guidance document entitled ``Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications'' to the Office of Policy,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Tammy Beckham, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Anne Taylor, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On March 27, 2020, the Coronavirus Aid, Relief, and Economic
Security Act (CARES Act) was signed into law. Section 3121 of the CARES
Act amends the FD&C Act by adding section 506J to the statute. Section
506J of the FD&C Act (21 U.S.C. 356j) provides FDA with new authorities
intended to help prevent or mitigate device shortages ``during, or in
advance of, a public health emergency'' declared under section 319 of
the Public Health Service Act (PHS Act) (42 U.S.C. 247d). Additionally,
on December 29, 2022, the Prepare for and Respond to Existing Viruses,
Emerging New Threats, and Pandemics Act (``PREVENT Pandemics Act'') was
signed into law as part of the Consolidated Appropriations Act, 2023,
Pub. L. 117-328 (hereafter referred to as the ``FY 2023 Omnibus'').
Section 2514(c) of the FY 2023 Omnibus directed FDA to issue or revise
guidance regarding requirements under section 506J and include a list
of each device product code for which a manufacturer of such device is
required to notify FDA in accordance with section 506J. Section 2514
the FY 2023 Omnibus amended section 506J to add section 506J(h),
``Additional Notifications'' and directed FDA to issue guidance ``to
facilitate voluntary notifications.''
    FDA is issuing this final guidance, ``Notifying FDA of a Permanent
Discontinuance or Interruption in Manufacturing of a Device Under
Section 506J of the FD&C Act'' (hereafter referred to as the ``506J
Guidance'') to assist stakeholders in the Agency's implementation of
section 506J. This guidance serves as the baseline for information
about notifications under section 506J during or in advance of any PHE.
FDA provides additional clarification on who is required to notify FDA,
when such notifications are required, what information FDA expects
manufacturers to include in such notifications, and how to submit
notifications. Additionally, FDA describes how FDA determines that a
device is in shortage and additional actions FDA may take to help
prevent or mitigate a potential device shortage.
    In the draft guidance ``Select Updates for the 506J Guidance: 506J
Device List and Additional Notifications,'' FDA proposes updates to the
506J Guidance. Specifically, FDA has developed a list of devices, by
FDA product code, for which a manufacturer of such devices is required
to notify FDA in accordance with section 506J (hereafter referred to as
the ``506J Device List''). The 506J Device List is based on the
requirements under section 506J(a). In section 2514 of the FY 2023
Omnibus, Congress directed FDA to issue guidance on the requirements
under section 506J and to include ``a list of each device product code
for which a manufacturer of such device is required to notify the
Secretary in accordance with section 506J.'' Thus, manufacturers of a
device on the 506J Device List must notify FDA in accordance with 506J
for each such device. For more information, manufacturers should see
the 506J Device List web page, available at https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/506j-device-list. Additionally, consistent with section 506J(h), FDA is proposing
to clarify for stakeholders that manufacturers may submit, and FDA may
receive, voluntary notifications regarding supply chain issues at any
time, unrelated to the declaration or potential declaration of a PHE.
The Agency invites comments on both the 506J Device List and the
clarification for stakeholders on voluntary notifications.
    A notice of availability of the draft guidance, ``Notifying FDA of
a Permanent Discontinuance or Interruption in Manufacturing of a Device
Under Section 506J of the FD&C Act,'' appeared in the Federal Register
of January 11, 2022 (87 FR 1417). FDA considered comments received and
revised the guidance as appropriate in response to the comments,
including providing additional clarifications such as when manufactures
should notify FDA of changes in status and when manufacturers should
provide 506J notification updates, and what information is required by
section 506J

and what additional information is helpful to FDA. Additionally, FDA
provided additional transparency regarding how FDA uses information
from 506J notifications.
    These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance,
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications,'' when finalized, will represent the current thinking of
FDA on ``Notifying FDA of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act.'' These
guidances do not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Notifying FDA of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act'' or
``Select Updates for the 506J Guidance: 506J Device List and Additional
Notifications'' may send an email request to [email protected]
to receive an electronic copy of the document. Please use the document
number GUI00021003 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:

------------------------------------------------------------------------
           Guidance                     Topic           OMB control No.
------------------------------------------------------------------------
``Notifying FDA of a Permanent  Shortages Data                 0910-0491
 Discontinuance or               Collection.
 Interruption in Manufacturing
 of a Device Under Section
 506J of the FD&C Act''.
------------------------------------------------------------------------

    Dated: November 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25458 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P


16021 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices research requirements) are covered by a separate ICR ( EPA ICR Number 0309.10, OMB Control Number 2060   0150). The health effects information will be used to determine if there are any products whose evaporative or combustion emissions pose an unreasonable risk to public health, thus meriting further investigation and potential regulation. This information is required for specific groups of fuels and additives as defined in the regulations. For example, all gasolines and gasoline additives which consist of only carbon, hydrogen, oxygen, nitrogen, and/ or sulphur, and which involve a gasoline oxygen content of less than 1.5 weight percent, fall into a `` baseline'' group. Oxygenates, such as ethanol and methyl tertiary butyl ether ( MTBE), when used in gasoline at oxygen levels of at least 1.5 weight percent, define separate `` nonbaseline'' groups for each oxygenate. Additives which contain elements other than carbon, hydrogen, oxygen, nitrogen, and/ or sulphur fall into separate `` atypical'' groups. There are similar grouping requirements for diesel fuels and additives. Manufacturers may perform the research independently or may join with other manufacturers to share in the costs for each applicable group. Several research consortiums ( groups of manufacturers) have been formed. The largest consortium, organized by the American Petroleum Institute ( API), represents most of the manufacturers of baseline and nonbaseline gasolines, diesel fuels, and additives. The research is structured into three tiers of requirements for each group. Tier 1 requires an emissions characterization and a literature search for information on the health effects of those emissions. Voluminous Tier 1 data were submitted by API and others in 1997. Tier 1 data were submitted for biodiesel and a water/ diesel fuel emulsion in 1998 and 2000, respectively. Tier 2 requires shortterm inhalation exposures of laboratory animals to emissions to screen for adverse health effects. Alternative Tier 2 testing can be required in lieu of the standard Tier 2 if EPA concludes that such testing would be more appropriate. The EPA reached that conclusion with respect to gasoline and gasolineoxygenate blends, and alternative requirements have been established for the API consortium for baseline gasoline and six gasoline oxygenate blends. A similar situation exists with the Ethyl Corporation and its manganese additive MMT, and alternative requirements have been established. The API submitted Tier 2 data for diesel in 1997. Tier 2 data were submitted for biodiesel and a water/ diesel fuel emulsion in 2000 and 2002, respectively. Tier 3 provides for follow up research, if necessary. No Tier 3 requirements have been established, and it is unlikely that any will be during the next three years. Thus, Tier 3 is not addressed in this ICR. Under section 211 of the Clean Air Act, ( 1) submission of the information is necessary for a manufacturer to obtain registration of a new fuel or additive, and thus be allowed to introduce that product into commerce, and ( 2) the information shall not be considered confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are identified on the form and/ or instrument, if applicable. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 15,175 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Manufacturers of Fuels and Fuel Additives. Estimated Number of Respondents: 8. Frequency of Response: On occasion. Estimated Total Annual Hour Burden: 60,700. Estimated Total Annual Cost: $ 6.8 million, includes $ 1.4 million annualized capital or O& M costs. Changes in the Estimates: There is a decrease of 6,767 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This decrease is due to the incorrect allocation of hours to some of the capital/ start up costs and operating and maintenance costs in the previous ICR. Dated: March 13, 2003. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 03   7971 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ RCRA   1999   0050, FRL   7475   8]

Agency Information Collection Activities: Submission for OMB Review; Comment Request; Part B Permit Application, Permit Modifications, and Special Permits AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( 44 U. S. C. 3501 et seq.), this document announces that the following Information Collection Request ( ICR) has been forwarded to the Office of Management and Budget ( OMB) for review and approval: Part B Permit Application, Permit Modifications, and Special Permits, EPA ICR # 1573.10, OMB No. 2050   0009, expires on March 31, 2003. The ICR describes the nature of the information collection and its expected burden and cost; where appropriate, it includes the actual data collection instrument.

DATES: Comments must be submitted on or before May 2, 2003. ADDRESSES: Follow the detailed instructions in SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: David Eberly, Office of Solid Waste ( 5303W), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 308   8645, or by e mail at eberly. david@ epa. gov.

SUPPLEMENTARY INFORMATION: EPA has established a public docket for this ICR under Docket ID No. RCRA   1999   0050, which is available for public viewing at the RCRA Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566   1744, and the telephone number for the RCRA Docket is ( 202) 566   0270. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16022 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the docket ID number identified above. Any comments related to this ICR should be submitted to EPA and OMB within 30 days of this notice, and according to the following detailed instructions: ( 1) Submit your comments to EPA online using EDOCKET ( our preferred method), by email to the rcradocket epa. gov, or by mail to: EPA Docket Center, Environmental Protection Agency, RCRA Docket, 5305T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and ( 2) Mail your comments to OMB at: Office of Information and Regulatory Affairs, Office of Management and Budget ( OMB), Attention: Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503. EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. Title: Part B Permit Application, Permit Modifications, and Special Permits, OMB Control No. 2050   0009, EPA ICR No. 1573.10, expiring on March 31, 2003. This is a request for extension of a currently approved collection. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. Abstract: Section 3005 of Subtitle C of RCRA requires treatment, storage or disposal ( TSD) facilities to obtain a permit. To obtain the permit, the TSD must submit an application describing the facility's operation. There are two parts to the RCRA permit application   part A and part B. Part A defines the processes to be used for treatment, storage, and disposal of hazardous wastes; the design capacity of such processes; and the specific hazardous wastes to be handled at the facility. Part B requires detailed site specific information such as geologic, hydrologic, and engineering data. In the event that permit modifications are proposed by the applicant or EPA, modifications must conform to the requirements under sections 3004 and 3005. This ICR provides a comprehensive discussion of the requirements for owner/ operators of TSDFs submitting applications for a part B permit or permit modification. The information collections contained in this ICR are divided into three sections: demonstrations and exemptions from requirements ( 40 CFR part 264), contents of the part B application ( 40 CFR part 270), and permit modifications and special permits ( 40 CFR part 270).

Demonstrations and Exemptions From Requirements 40 CFR part 264 contains minimum standards for TSDFs consisting of both administrative and technical requirements. Owner/ operators may obtain exemption from certain requirements by submitting demonstrations to EPA. In most cases, these demonstrations will be submitted along with the part B application. Section 264.90 allows owner/ operators to submit a demonstration for exemption from the subpart F requirements regarding releases to the uppermost aquifer. In addition, owner/ operators of tank systems, surface impoundments, waste piles, landfills, land treatment facilities and incinerators may apply for exemptions from certain technical requirements by submitting demonstrations under § § 264.193, .221, .251, .272, .301 and .344, respectively. Contents of the Part B Application 40 CFR part 270 contains requirements for owner/ operators submitting a part B permit application. Section 270.1 allows owner/ operators of certain facilities closing by removal or decontamination to petition for an exemption from postclosure permit requirements. Section 270.10 requires owner/ operators of certain facilities to provide information on the potential for public exposure resulting from unit related releases. Part B of the permit application consists of the general and specific information requirements contained in § § 270.14 through 270.29. These part B information requirements reflect the standards promulgated in 40 CFR part 264. Under § 270.14( a), owner/ operators who can demonstrate that the information prescribed in part B cannot be provided to the extent required may receive case by case allowances from EPA. General information requirements are outlined in § 270.14. Sections 270.14( b)( 1)   ( 14) require owner/ operators to provide information on compliance with general facility standards. Financial assurance information is required under § § 270.15   .18. Section 270.14( b)( 19) requires owner/ operators to submit a topographical map, and § 270.14( b)( 21) covers special requirements for owner/ operators of land disposal facilities granted case by case extensions under § 268.5 or petitions under § 268.6. Information on ground water quality and monitoring programs for land disposal facilities is discussed under § § 270.14( c)( 1)   ( 8). Section 270.14( d) establishes part B information requirements for solid waste management units. In addition to the general part B information that must be submitted by all owner/ operators of TSDFs, there are unique information requirements related to the type of unit for which the owner/ operator is seeking a permit. The requirements under § § 270.15   .21 and .23 address specific requirements for the following types of units: containers, tank systems, surface impoundments, waste piles, incinerators, land treatment units, landfills, boilers and industrial furnaces, and miscellaneous units. Sections 270.24 and 270.25 apply to facilities with process vents or equipment subject to the requirements of 40 CFR parts 264/ 265, subparts AA and BB, respectively. Section 270.26 applies to facilities with drip pads subject to the requirements of 40 CFR parts 264/ 265, subpart W. Some owner/ operators may also be required to submit a schedule of compliance leading to compliance with RCRA and regulations as part of their application. The requirements for schedules of compliance are contained in § 270.33.

Permit Modifications and Special Permits Sections 270.40 through 270.42 address the requirements for permit modifications. Section 270.40 applies to owner/ operators transferring ownership or operational control of a facility. These owner/ operators must submit Class 1 permit modifications as well as a written agreement containing specific transfer information. Requirements for owner/ operators submitting permit modifications at the request of the Agency are contained in § 270.41. Requirements for Class 1, 2, and 3 permit modifications submitted at the VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1 16023 Federal Register / Vol. 68, No. 63 / Wednesday, April 2, 2003 / Notices request of the permittee are contained in § 270.42( a)   ( c). Section 270.42( d) allows permittees to request that the Agency determine the classification for a specific modification. Sections 270.42( e) and ( g) discuss requirements for temporary authorization and permit modifications for newly regulated wastes and units, respectively. In 40 CFR part 264, subpart S, EPA promulgated regulations for corrective action management units ( CAMUs). 40 CFR 264.552( d) requires owner/ operators to prepare and submit information that enables EPA to designate a CAMU. Requirements for permit renewal are contained in § § 270.50 and 270.51. In order to renew an expiring permit, owner/ operators must submit an application containing the information required under § 270.14 and the applicable sections of § § 270.15 through 270.29. Sections 270.60 and 270.62 through 270.65 address the requirements associated with special types of permits. These include permits by rule ( § 270.60); hazardous waste incinerator permits ( § 270.62); permits for land treatment demonstrations using field test or laboratory analyses ( § 270.63); interim permits for UIC wells ( § 270.64); and research, development and demonstration permits ( § 270.65). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15. The Federal Register document required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on July 23, 1999 ( 64 FR 39986); no comments were received. Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 165 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Respondents/ Affected Entities: Business. Estimated Number of Respondents: 74. Frequency of Response: Occasional. Estimated Total Annual Hour Burden: 12,209 hours. Estimated Total Annualized Capital, Operating/ Maintenance Cost Burden: $ 2,468,000. Changes in the Estimates: There is a decrease of 165,523 hours in the total estimated burden currently identified in the OMB Inventory of Approved ICR Burdens. This is due to a lower number of affected facilities.

Dated: March 25, 2003. Oscar Morales, Director, Collection Strategies Division. [ FR Doc. 03   7972 Filed 4   1   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0085; FRL   7290   2]

Product Registration Maintenance Fees; Renewal of Pesticide Information Collection Activities and Request for Comments AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In compliance with the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.) this notice announces that EPA is seeking public comment on the following Information Collection Request ( ICR): Product Registration Maintenance Fees ( EPA ICR No. 1214.06, OMB Control No. 2070   0100). This is a request to renew an existing ICR that is currently approved and due to expire January 31, 2004. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget ( OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection. DATES: Written comments, identified by the docket ID number OPP   2003   0085, must be received on or before June 2, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit III. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Nancy Vogel, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6475; fax number: ( 703) 305   5884; e mail address: vogel. nancy@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

You may be potentially affected by this action if you are an individual or entity engaged in activities related to the registration of a pesticide product. Potentially affected entities may include, but are not limited to:   Pesticide and other agricultural chemical manufacturing ( NAICS 325320), e. g., Pesticide registrants. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed above could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. How Can I Get Copies of this Document and Other Related Information?

A. Docket EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0085. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal VerDate Jan< 31> 2003 15: 59 Apr 01, 2003 Jkt 200001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 02APN1. SGM 02APN1


                                     FORM R Section 313 of the Emergency Planning and Community Right-to-Know Act of 1986, also Known as Title III of the Superfund Amendments and Reauthorization Act TRI Facility ID Number

                                        Toxic Chemical, Category, or Generic Name

This section only applies if you are revising or withdrawing a previously submitted form, otherwise leave blank. Revision (Enter up to two code(s))

Withdrawal (Enter up to two code(s))

IMPORTANT: See instructions to determine when "Not Applicable (NA)" boxes should be checked.                  PART I.  FACILITY IDENTIFICATION INFORMATION SECTION 1. REPORTING YEAR            ________ SECTION 2.  TRADE SECRET INFORMATION 2.1 Are you claiming the toxic chemical identified on page 2 as a trade secret? 2.2 Is this copy    Sanitized	  Unsanitized (Answer only if "Yes" in 2.1)

Yes	(Answer question 2.2;  attach substantiation forms)

No	(Do not answer 2.2;  go to Section 3)

SECTION 3.  CERTIFICATION     (Important: Read and sign after completing all form sections.)  I hereby certify that I have reviewed the attached documents and that, to the best of my knowledge and belief, the submitted information is true and complete and that the amounts and values in this report are accurate based on reasonable estimates using data available to the preparers of this report. Name and official title of owner/operator or senior management official: Signature: Date signed:

SECTION 4. FACILITY IDENTIFICATION	 4.1 Facility or Establishment Name

TRI Facility ID Number

BIA Code

Physical Street Address

Mailing Address (if different from physical street address)

City/County/State/ZIP Code

City/State/ZIP Code

Country (Non-US)

4.2 This report contains information for:  (Important: Check a or b; check c or d if applicable) a.

An entire facility b.

Part of a facility c.

A federal facility d.

GOCO 4.3 Technical Contact Name

Telephone Number (include area code and ext.)

Email Address

4.4 Public Contact Name

Telephone Number (include area code and ext.)

Email Address

4.5 NAICS Code(s)  (6 digits) Primary

a. b. c. d. e. f. 4.6 Dun & Bradstreet Number(s) (9 digits) a.

b. SECTION 5. Parent Company Information 5.1 Name of U.S. Parent Company (for TRI Reporting purposes)

No U.S. Parent Company  (for TRI Reporting purposes)

5.2 Parent Company's Dun & Bradstreet Number NA

 EPA Form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.                                     FORM R                     Part II. CHEMICAL-SPECIFIC INFORMATION TRI Facility ID Number

                                        Toxic Chemical, Category, or Generic Name

SECTION 1. TOXIC CHEMICAL IDENTITY       (Important: DO NOT complete this section if you are reporting a mixture component in Section 2 below.) 1.1 CAS Number (Important:  Enter only one number exactly as it appears on the Section 313 list. Enter category code if reporting a chemical category.)

1.2 Toxic Chemical or Chemical Category Name (Important: Enter only one name exactly as it appears on the Section 313 list.)

1.3 Generic Chemical Name (Important: Complete only if Part I, Section 2.1 is checked "Yes". Generic Name must be structurally descriptive.)

SECTION 2. MIXTURE COMPONENT IDENTITY      (Important: DO NOT complete this section if you completed Section 1.) 2.1 Generic Chemical Name Provided by Supplier (Important: Maximum of 70 characters, including numbers, letters, spaces, and punctuation.)

SECTION 3. ACTIVITIES AND USES OF THE TOXIC CHEMICAL AT THE FACILITY      (Important: Check all that apply.) 3.1 Manufacture the toxic chemical: 3.2 Process the toxic chemical:  3.3 Otherwise use the toxic chemical: a.		Produce  b.    Import a.		As a reactant b.		As a formulation component c.		As an article component d.		Repackaging e.		As an impurity f.		Recycling

                Enter 4-digit code(s) from instruction package a.		As a chemical               processing aid b.		As a manufacturing aid c.		Ancillary or other use

                Enter 4-digit code(s) from instruction package

	If Produce or Import c.		For on-site use/processing d.		For sale/distribution e.		As a byproduct f.		As an impurity

SECTION 4. MAXIMUM AMOUNT OF THE TOXIC CHEMICAL ON-SITE AT ANY TIME DURING THE CALENDAR YEAR 4.1                                         (Enter two-digit code from instruction package.)

SECTION 5. QUANTITY OF THE TOXIC CHEMICAL ENTERING EACH ENVIRONMENTAL MEDIUM ON-SITE

A. Total Release   (pounds/year*)      (Enter a range code** or estimate) B. Basis of Estimate      (Enter code) C. Percent from Stormwater 5.1 Fugitive or non-point  air emissions NA

5.2 Stack or point air emissions NA

5.3 Discharges to receiving streams or water bodies (Enter one name per box) NA

            Stream or Water Body Name Reach Code (optional)

5.3.1

5.3.2

If additional pages of Part II, Section 3.2 and 3.3 are attached, indicate the total number of pages in this box  and indicate the Part II, Section 3.2 and 3.3 page number in this box.                (Example: 1, 2, 3, etc.)                                 If additional pages of Part II, Section 5.3 are attached, indicate the total number of pages in this box  and indicate the Part II, Section 5.3 page number in this box.                           (Example: 1, 2, 3, etc.) EPA form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.	*For Dioxin or Dioxin-like compounds, report in grams/year. 	**Range Codes: A= 1-10 pounds; B= 11-499 pounds; C= 500-999 pounds.

                                    FORM R               Part II. CHEMICAL-SPECIFIC INFORMATION (CONTINUED) TRI Facility ID Number

                                         Toxic Chemical, Category, or Generic Name

SECTION 5. QUANTITY OF THE TOXIC CHEMICAL ENTERING EACH ENVIRONMENTAL MEDIUM ON-SITE (continued)

                                      NA A. Total Release   (pounds/year*)  (Enter a range        code** or estimate) B. Basis of Estimate       (Enter code) 5.4-5.5 Disposal to land on-site

5.4.1 Class I Underground   Injection Wells                                       

5.4.2 Class II-V Underground Injection Wells                                       

5.5.1A RCRA Subtitle C landfills

5.5.1B Other landfills

5.5.2 Land treatment/application farming

5.5.3A RCRA Subtitle C  surface impoundments

5.5.3B Other surface impoundments

5.5.4 Other disposal

Optional Waste Rock Piles Information You may check this box if your Section 5.5 quantities include "waste rock piles."   Enter quantity of "waste rock piles"  (pounds/year*)

SECTION 6. TRANSFER(S) OF THE TOXIC CHEMICAL IN WASTES TO OFF-SITE LOCATIONS  6.1	DISCHARGES TO PUBLICLY OWNED TREATMENT WORKS (POTWs)		NA     6.1.___ POTW Name POTW Address

City

County

State

ZIP

A. Quantity Transferred to this POTW        (pounds/year*) (Enter range code**or estimate)  B. Basis of Estimate       (Enter code) C. Disposal/Treatment (Enter code) 1. 1. 1. PW 2. 2. 2. PW 3. 3. 3. PW If additional pages of Part II, Section 6.1 are attached, indicate the total number of pages in this box   and indicate the Part II, Section 6.1 page number in this box.   (Example: 1, 2, 3, etc.) SECTION 6.2  TRANSFERS TO OTHER OFF-SITE LOCATIONS	NA     6.2.___  Off-Site EPA Identification Number (RCRA ID No.)

Off-Site Location Name:

Off-Site Address:

City

County

State

ZIP

Country (non-US)

Is this location under control of reporting facility or parent company?		  Yes		  No EPA form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.	*For Dioxin or Dioxin-like compounds, report in grams/year. 	**Range Codes: A= 1-10 pounds; B= 11-499 pounds; C= 500-999 pounds.

                                    FORM R               Part II. CHEMICAL-SPECIFIC INFORMATION (CONTINUED) TRI Facility ID Number

                                        Toxic Chemical, Category, or Generic Name

SECTION 6.2. TRANSFERS TO OTHER OFF-SITE LOCATION (CONTINUED)  A. Total Transfer   (pounds/year*)         (Enter a range code** or estimate)

B. Basis of Estimate       (Enter code) C. Type of Waste Treatment/Disposal/       Recycling/Energy Recovery (Enter code) 1. 1. 1. M 2. 2. 2. M 3. 3. 3. M 6.2____  Off-Site EPA Identification Number (RCRA ID No.)

Off-Site Location Name:

Off-Site Address:

City

County

State

ZIP

Country (non-US)

Is this location under control of reporting facility or parent company?	 Yes  	 No   A. Total Transfer   (pounds/year*)         (Enter a range code** or estimate)

B. Basis of Estimate       (Enter code) C. Type of Waste Treatment/Disposal/       Recycling/Energy Recovery (Enter code) 1. 1. 1. M 2. 2. 2. M 3. 3. 3. M SECTION 7A. ON-SITE WASTE TREATMENT METHODS AND EFFICIENCY    Not Applicable (NA) - Check here if no on-site waste treatment method is applied to any waste stream containing the toxic chemical or chemical category. a. General Waste Stream     (Enter code)                      b. Waste Treatment Method(s) Sequence                                                      (Enter 3- or 4-character code(s)) c. Waste Treatment Efficiency      (Enter 2 character code)                                      7A.1a 7A.1b

1

2 5 8

                                     7A.1c

3

4 7

6

                                     7A.2a 7A.2b

1 4

2

                                     7A.2c

3

5 8

6

7

                                     7A.3a 7A.3b

1 4 7

2

                                     7A.3c

3 6

5 8

                                     7A.4a 7A.4b

1 4 7

2 5 8

                                     7A.4c

3 6

                                     7A.5a 7A.5b

1 4 7

2 5 8

                                     7A.5c

3 6

If additional pages of Part II, Section 6.2/7.A are attached, indicate the total number of pages in this box  and indicate the Part II, Section 6.2/7.A  page number in this box.                           (Example: 1, 2, 3, etc.) EPA form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.	*For Dioxin or Dioxin-like compounds, report in grams/year. 	**Range Codes: A= 1-10 pounds; B= 11-499 pounds; C= 500-999 pounds.                                     FORM R TRI Facility ID Number

              Part II. CHEMICAL-SPECIFIC INFORMATION (CONTINUED) Toxic Chemical, Category, or Generic Name

SECTION 7B. ON-SITE ENERGY RECOVERY PROCESSES    NA Check here if no on-site energy recovery is applied to any waste stream containing the toxic chemical or chemical category. Energy Recovery Methods (Enter 3-character code(s))

                                       1

                                       2

                                       3

SECTION 7C. ON-SITE RECYLING PROCESSES    NA Check here if no on-site recycling is applied to any waste stream containing the toxic chemical or chemical category. Recycling Methods (Enter 3-character code(s))

                                      1.

                                      2.

                                      3.

SECTION 8. SOURCE REDUCTION AND WASTE MANAGEMENT

Column A Prior Year (pounds/year*) Column B Current Reporting Year (pounds/year*) Column C Following Year (pounds/year*) Column D Second Following Year (pounds/year*) 8.1  -  8.7 Production-Related Waste Managed

8.1a Total on-site disposal to Class I Underground Injection Wells, RCRA Subtitle C landfills, and other landfills

8.1b Total other on-site disposal or other releases

8.1c Total off-site disposal to Class I Underground Injection Wells, RCRA Subtitle C landfills, and other landfills

8.1d Total other off-site disposal or other releases

8.2 Quantity used for energy recovery on-site

8.3 Quantity used for energy recovery off-site

8.4 Quantity recycled on-site

8.5 Quantity recycled off-site

8.6 Quantity treated on-site

8.7 Quantity treated off-site

8.8 Non-Production-Related Waste Managed**

8.9  Production ratio or  Activity ratio (select one and enter value to the right)

8.10 Did your facility engage in any newly implemented source reduction activities for this chemical during the reporting year?  If so, complete the following section; if not, check NA.	NA

Source Reduction Activities  (Enter code(s))                  Methods to Identify Activity (Enter code(s)) Estimated annual reduction (Enter code(s)) (optional) 8.10.1

a. b. c. d. 8.10.2

a. b. c. d. 8.10.3

a. b. c. d. 8.10.4

a. b. c. d. EPA form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.	*For Dioxin or Dioxin-like compounds, report in grams/year. 	**Includes quantities released to the environment or transferred off-site as a result of remedial actions, catastrophic events, or other one-time events not associated with production processes                                     FORM R TRI Facility ID Number

              Part II. CHEMICAL-SPECIFIC INFORMATION (CONTINUED) Toxic Chemical, Category, or Generic Name

SECTION 8.11. DISPOSAL OR OTHER RELEASES, SOURCE REDUCTION, AND RECYCLING ACTIVITIES  8.11 If you wish to submit additional optional information on source reduction, recycling, or pollution control activities, provide it here.

SECTION 9. MISCELLANEOUS INFORMATION  9.1 If you wish to submit any miscellaneous, additional, or optional information regarding your Form R submission, provide it here.

EPA form 9350 -1 (Rev. 09/2017). Previous editions are obsolete.


[Federal Register: August 2, 2010 (Volume 75, Number 147)]
[Notices]
[Page 45195-45196]
[DOCID:fr02au10-144]

=======================================================================
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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.

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

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 17, 2010.

ADDRESSES: 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://
www.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 23, 2010.
Ryan Paquet,
Acting Director, Office of Hazardous Materials, Special Permits and
Approvals.

----------------------------------------------------------------------------------------------------------------
                                                                   Regulation(s)       Nature of special permit
    Application No.        Docket No.         Applicant               affected                  thereof
----------------------------------------------------------------------------------------------------------------
                                          MODIFICATION SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
11077-M................  .............  Department of          49 CFR 173.226(b);     To modify the special
                                         Defense, Scott AFB,    173.227(b).            permit by removing one
                                         IL.                                           Division 6.1 hazardous
                                                                                materials and adding an
                                                                                additional Division 6.1
                                                                                hazardous material.
12783-M................  .............  CryoSurgery, Inc.,     49 CFR 173.304a(a)     To modify the special
                                         Nashville, TN.         (1); 173.306(a).       permit to authorize
                                                                                additional Division 2.2
                                                                                hazardous materials.
13327-M................  .............  HAWK Corporation,      49 CFR 172.101, B15..  To modify the special
                                         Ardmore, OK.                                  permit to allow manways
                                                                                manufactured under this
                                                                                special permit to be
                                                                                installed on fiberglass
                                                                                cargo tanks manufactured
                                                                                under the terms of other
                                                                                special permits.
14469-M................  .............  Space Systems/Loral,   49 CFR 172.101 column  To modify the special
                                         Palo Alto, CA.         (9B).                  permit to add ammonium
                                                                                hydroxide.
14844-M................  .............  Northern Air Cargo,    49 CFR 173.302(f)....  To reissue the special
                                         Anchorage, AK.                                permit orginally issued
                                                                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14860-M................  .............  Alaska Airlines,       49 CFR 173.302(f)....  To reissue the permit
                                         Seattle, WA.                                  originally issued on an
                                                                                emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.

14903-M................  .............  Hageland Aviation      49 CFR 173.302(f)....  To reissue the special
                                         Services, Anchorage,                          permit originally issued
                                         AK.                                           on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14905-M................  .............  Frontier Flying        49 CFR 173.302(1)....  To reissue the special
                                         Services, Inc.,                               permit originally issued
                                         Fairbanks, AK.                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14906-M................  .............  Ryan Air, Inc.         49 CFR 173.302(f)....  To reissue the special
                                         (Former Grantee:                              permit originally issued
                                         Arctic                                        on an emergency basis
                                         Transportation                                authorizing the
                                         Services),                                    transportation in
                                         Anchorage, AK.                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14907-M................  .............  Conocophillips         49 CFR 172.101 Column  To reissue the special
                                         Alaska, Inc.,          (9B).                  permit originally issued
                                         Anchorage, AK.                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14909-M................  .............  Lake Clark Air, Inc.,  49 CFR 173.304(f)....  To reissue the special
                                         Port Alsworth, AK.                            permit originally issued
                                                                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14926-M................  .............  Lynden Air Cargo,      49 CFR 173.302(f)....  To reissue the special
                                         Anchorage, AK.                                permit originally issued
                                                                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14927-M................  .............  Era Aviation, Inc.,    49 CFR 173.302(f)....  To reissue the special
                                         Anchorage, AK.                                permit originally issued
                                                                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
14931-M................  .............  Tucker Aviation Inc.,  49 CFR 173.302(f)....  To reissue the special
                                         Dillingham, AK.                               permit originally issued
                                                                                on an emergency basis
                                                                                authorizing the
                                                                                transportation in
                                                                                commerce of compressed
                                                                                oxygen without rigid
                                                                                outer packaging when no
                                                                                other means of
                                                                                transportation exist.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-18711 Filed 7-30-10; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)]
[Notices]
[Pages 42098-42099]
[FR Doc No: 2015-17422]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: EC15-153-000.
    Applicants: PowerOne Corporation, ResCom Energy LLC.
    Description: Supplement to June 2, 2015 Application under Section
203 of ResCom Energy LLC, et al.
    Filed Date: 7/9/15.
    Accession Number: 20150709-5300.
    Comments Due: 5 p.m. ET 7/20/15.

    Docket Numbers: EC15-165-000.
    Applicants: Samchully Power & Utilities 1 LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of Samchully
Power & Utilities 1 LLC.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5103.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: EC15-166-000.
    Applicants: Beech Ridge Energy LLC, Beech Ridge Energy II LLC,
Beech Ridge Energy Storage LLC, Bishop Hill Energy LLC, Bishop Hill
Energy III LLC, Bishop Hill Interconnection LLC, Buckeye Wind Energy
LLC, California Ridge Wind Energy LLC, Forward Energy LLC, Grand Ridge
Energy LLC, Grand Ridge Energy II LLC, Grand Ridge Energy III LLC,
Grand Ridge Energy IV LLC, Grand Ridge Energy V LLC, Grand Ridge Energy
Storage LLC, Gratiot County Wind LLC, Gratiot County Wind II LLC,
Invenergy TN LLC, Judith Gap Energy LLC, Prairie Breeze Wind Energy
LLC, Prairie Breeze Wind Energy II LLC, Prairie Breeze Wind Energy III
LLC, Sheldon Energy LLC, Spring Canyon Energy LLC, Stony Creek Energy
LLC, Vantage Wind Energy LLC, Willow Creek Energy LLC, Wolverine Creek
Energy LLC, Wolverine Creek Goshen Interconnection, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers and Expedited Action of Beech
Ridge Energy LLC, et. al.
    Filed Date: 7/10/15.

    Accession Number: 20150710-5105.
    Comments Due: 5 p.m. ET 7/31/15.
    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER13-1371-001; ER13-1371-002.
    Applicants: GP Big Island, LLC.
    Description: Supplement to the June 23, 2015 and July 1, 2015 GP
Big Island, LLC tariff filings.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5107.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-528-002.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Compliance filing: OATT Order No. 676-H Revised Second
Compliance Filing to be effective 5/15/2015.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5136.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2146-000.
    Applicants: PJM Interconnection, L.L.C., American Transmission
Systems, Incorporated, Pennsylvania Electric Company, Trans-Allegheny
Interstate Line Company, West Penn Power Company, The Potomac Edison
Company, Monongahela Power Company, Metropolitan Edison Company.
    Description: Section 205(d) Rate Filing: American Transmission
Systems Inc., et al. Filing of New Service Agreements to be effective
9/7/2015.
    Filed Date: 7/9/15.
    Accession Number: 20150709-5196.
    Comments Due: 5 p.m. ET 7/30/15.

    Docket Numbers: ER15-2148-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Section 205(d) Rate Filing: Original Service Agreement
No. 4189 (Queue Z2-012) to be effective 6/10/2015.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5041.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2149-000.
    Applicants: Century Marketer LLC.
    Description: Baseline eTariff Filing: MBRA Tariff to be effective
9/24/2015.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5084.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2150-000.
    Applicants: PJM Interconnection, L.L.C., PPL Electric Utilities
Corporation.
    Description: Section 205(d) Rate Filing: PPL Electric submits
Coordination Agreement No. 1015 with Borough of Catawissa to be
effective 1/1/2014.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5085.

    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2151-000.
    Applicants: PJM Interconnection, L.L.C., PPL Electric Utilities
Corporation.
    Description: Section 205(d) Rate Filing: PPL submits Coordination
Agreement No. 1027 with Borough of Watsontown to be effective 1/1/2014.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5086.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2152-000.
    Applicants: Niagara Mohawk Power Corporation, New York Independent
System Operator, Inc.
    Description: Section 205(d) Rate Filing: Niagara Mohawk filing of
an amended CRA between NMPC and RG&E to be effective 5/29/2015.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5088.
    Comments Due: 5 p.m. ET 7/31/15.

    Docket Numbers: ER15-2153-000.
    Applicants: AEP Generation Resources Inc.
    Description: Section 205(d) Rate Filing: Ohio Power Supply
Agreement Cancellation to be effective 6/1/2015.
    Filed Date: 7/10/15.
    Accession Number: 20150710-5123.
    Comments Due: 5 p.m. ET 7/31/15.

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

    Docket Numbers: ES15-37-000.
    Applicants: Michigan Electric Transmission Company, LLC.
    Description: Supplement to June 22, 2015 Application under Section
204 of Michigan Electric Transmission Company, LLC.
    Filed Date: 7/9/15.
    Accession Number: 20150709-5302.
    Comments Due: 5 p.m. ET 7/20/15.

    Docket Numbers: ES15-38-000.
    Applicants: MDU Resources Group, Inc.
    Description: Application of MDU Resources Group, Inc. for
authorization is issue short-term securities in the form of promissory
notes and/or commercial paper.
    Filed Date: 7/9/15.
    Accession Number: 20150709-5303.
    Comments Due: 5 p.m. ET 7/30/15.

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

    Dated: July 10, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-17422 Filed 7-15-15; 8:45 am]
BILLING CODE 6717-01-P


9Comments on U.S. Environmental Protection Agency Proposed Rule, "Control of Air Pollution from Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards," RIN 2060-AQ86

 V.F.6.a.  Gasoline Used in Military Applications
      In our diesel fuel program, we provided an exemption for diesel fuel used in tactical military vehicles and nonroad engines and equipment with a national security exemption (NSE) from the vehicle and engine emissions standards.  Due to national security considerations, some of EPA's existing regulations allow the military to request and receive NSEs for vehicles, engines, and equipment from emissions regulations if the operational requirements for such vehicles, engines, or equipment warrant such an exemption.  Fuel used in these applications would also be exempt if it is used in tactical military vehicles, engines, or equipment that are not covered by an NSE but, for national security reasons (such as the need to be ready for immediate deployment overseas), these  applications need to be fueled on the same fuel as  those with an NSE.  We are proposing this exemption under the proposed Tier 3 gasoline program.