Comment Info: =================

General Comment:Please attach these documetns to Docket# PHMSA-2008-0062.


Listed below are the requests from EDF received via a phone call
regarding U.S. Inventory of Greenhouse Gas Emissions and Sinks data.
After each request is the response which is based on publicly available
information.

Request:  He wants to understand the Gas STAR source pie charts that we
put in our presentations - specifically, what are the inventory sources
that make up those pie pieces.

Response:  Consult the Energy Section 3 and Sections 3.4 and 3.5 of the
Annexes in the 2007 U.S. Inventory found at   HYPERLINK
"http://epa.gov/climatechange/emissions/usgginv_archive.html"
epa.gov/climatechange/emissions/usgginv_archive.html .  The individual
source categories and their methane emissions begin on page A-143 for
natural gas and page A-151 for petroleum in Annex 3.  The Annex more
thoroughly covers the methodology used to arrive at the results in
Section 3.

Request:  He noted that REC reductions are greater than the entire
inventory number for well completions and had a general question about
how we deal with that when removing NGS reductions from the inventory.
Also wanted to talk generally about our policy for updating the
inventory and why we haven't done that for this source.

Response:  Generally, when estimating emissions from the natural gas
industry in the U.S. GHG Inventory, CH4 emissions are quantified for
each segment of the industry (e.g., production, processing,
transmission, distribution) based on a bottom up assessment of different
emissions sources. Reductions reported by Gas STAR partners are
subtracted at the segment level.  Please see Annex 3.4 in the 2007
Inventory.

The Inventory is annually subject to a peer review, a public review and
review by an international team of experts.  Based upon issues
identified during these reviews, as well as experience gained in the
Natural Gas STAR program, the U.S. strives to continually improve the
national Inventory.  EPA has undertaken efforts in the past couple of
years to update the underlying activity data used in the inventory for a
number of sources, including well completions and we are evaluating the
appropriateness of incorporating revised data into the National
Inventory.

We have communicated preliminary revised emissions estimates to external
stakeholders to enable a dialogue among all interested parties about the
potential magnitude of emissions from this industry.  We have used many
of these revised emissions estimates as the foundation for the analysis
used to support development of reporting requirements for this industry
under the Mandatory GHG Reporting Rule. We also intend to incorporate
these revised emissions estimates into our next annual inventory
submission to the United Nations Framework Convention on Climate Change.

Presently, REC reductions reported in the Natural Gas STAR body of work
is larger than well completion venting in the inventory on an annual
basis.  Section 3 of the inventory discusses improvements and future
plans for each sector.  For the natural gas industry, the planned
improvements are discussed on page 3-46.  For the petroleum industry,
the planned improvements are discussed on page 3-51.

In a New York Times article published on October 15, 2009, it is
mentioned that the EPA is currently reviewing and revising methane
emissions from U.S. gas wells.  As a result, the EPA found that the
amount emitted by routine operations at gas wells is approximately 12
times larger than the existing estimate of 9 Bcf.  The NYT article can
be found here at   HYPERLINK
"http://www.nytimes.com/2009/10/15/business/energy-environment/15degrees
.html#"
www.nytimes.com/2009/10/15/business/energy-environment/15degrees.html# .

EPA has included these revised emission numbers in the MRR.
Specifically, these new numbers are in the TSD, explained in Appendix B
(pages 79 to 85) and used in the TSD on page 9.  On page 82, the new
2007 U.S. emissions from well completion and workover venting is
approximately 120 Bcf.  The TSD can be found here at   HYPERLINK
"http://www.epa.gov/climatechange/emissions/downloads10/Subpart-W_TSD-02
2310.pdf"
www.epa.gov/climatechange/emissions/downloads10/Subpart-W_TSD-022310.pdf
.

Request:  It looked to him like NGS reductions, which include both oil
and natural gas production operations, are only removed from the natural
gas portion of the inventory - why is this?  If we were to differentiate
the emission reductions associated with the oil sector, what would these
be (sources and volumes)?

Response:  The methodology in Annex 3 of the inventory indicates how
Natural Gas STAR reductions are applied to the natural gas systems
sector.

Natural Gas STAR considers data at the level of the production sector,
rather than further dividing its reporting into natural gas and
petroleum.  At the same time, the inventory considers data at the level
of natural gas systems production & petroleum systems production.  Often
a Natural Gas STAR reduction activity straddles both natural gas systems
and petroleum systems and is therefore inherently an overall production
sector activity.  The Natural Gas STAR production sector reductions are
not further deconstructed and are thus applied to natural gas systems
production sector.  For example, vapor recovery units (VRUs) can be
installed on both condensate (gas) and storage (oil) tanks, but it is
not a Natural Gas STAR reporting requirement to specify which.

Request:  Do we have a number (%) we can provide publicly about the
amount of gas lost from what comes out of the ground versus what gets to
consumers/export?

Response:  This percentage is not a published statistic but can be
roughly calculated from public sources such as the inventory and such as
EIA gas production data.  It is also important to understand numerical
treatment of gas imports and exports, NGL imports and exports, gas
reinjected, gas consumed on site, gas unaccounted for due to intrinsic
metering errors, and distinguishing between methane versus natural gas
data, which all have first order effects on the resulting percentage.
Any result using this calculation method would not apply to any specific
site given the top-down nature of the calculation.

Request:  Are changes/updates to the national inventory tracked every
year?  In particular, he noticed that there were changes to past year
volumes in the most recent inventory and wondering why those would
change retroactively.

Response:  Yes, for each annual inventory cycle, the entire time series
is considered and updated.  The entire time series of 1990 to the
present reporting year is updated annually because revised activity data
is applied as it is available.  It is not uncommon for EIA or other data
sources to issue revised estimates for years in the recent past, and
such revisions are tracked by the inventory.  Any changes in the data
sources used are be noted in the executive summary and introduction
sections of the inventory.

 PAGE

 PAGE   1


Information requested by the US EPA Motor Fuel Program   For Fiscal Year 1999 2000 Volume of gasoline sold in the state: 14.6 billion gallons Volume of diesel sold in the state: 2.6 billion gallons Volume of gasoline CARB inspected 0.968 billion gallons ( 6.6% of total sold) Volume of diesel CARB inspected 0.333 billion gallons ( 12.3% of total sold)

Total number of samples obtained by CARB 2452 Number of fuel samples determined to be in violation 13 VIOLATION RATE ( based on numbers of samples) 0.5%

Volume of gasoline determined to be in violation 0.0190 billion gallons VIOLATION RATE FOR GASOLINE ( based on volume) 1.9%

Volume of diesel determined to be in violation 0.0038 billion gallons VIOLATION RATE FOR DIESEL ( based on volume) 1.1%


[Federal Register: January 17, 2008 (Volume 73, Number 12)]
[Proposed Rules]
[Page 3226-3227]
[DOCID:fr17ja08-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-1075, FRL-8506-3]

Revisions to the California State Implementation Plan, Kern
County Air Pollution Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the Kern County Air
Pollution Control District (KCAPCD) portion of the California State
Implementation Plan (SIP). These revisions concern particulate matter
(PM-10) emissions from ambient dust and propellant and rocket testing.
We are proposing to approve local rules under the Clean Air Act as
amended in 1990 (CAA or the Act).

DATES: Any comments on this proposal must arrive by February 19, 2008.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2007-1075, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. Follow

the online instructions.
     E-mail<EMAIL_ADDRESS>     Mail or deliver: Andrew Steckel (Air-4), U.S.
Environmental Protection Agency Region IX, 75 Hawthorne Street, San
Francisco, CA 94105.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov,

including any personal information provided, unless the comment
includes Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Information that you
consider CBI or otherwise protected should be clearly identified as
such and should not be submitted through http://www.regulations.gov or e-mail.

http://www.regulations.gov is an ``anonymous access'' system, and EPA will not

know your identity or contact information unless you provide it in the
body of your comment. If you send e-mail directly to EPA, your e-mail
address will be automatically captured and included as part of the
public comment. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment.
    Docket: The index to the docket for this action is available
electronically at http://www.regulations.gov and in hard copy at EPA Region

IX, 75 Hawthorne Street, San Francisco, California. While all documents
in the docket are listed in the index, some information may be publicly
available only at the hard copy location (e.g., copyrighted material),
and some may not be publicly available in either location (e.g., CBI).
To inspect the hard copy materials, please schedule an appointment
during normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Al Petersen, Rules Office (AIR-4),
U.S. Environmental Protection Agency, Region IX,<PHONE_NUMBER>,
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: This proposal addresses the approval of
KCAPCD Rules 404.1 and 431. In the Rules and Regulations section of
this Federal Register, we are approving these local rules in a direct
final action without prior proposal because we believe this SIP
revision is not controversial. If we receive adverse comments, however,
we will publish a timely withdrawal of the direct final rule and
address the comments in subsequent action based on this proposed rule.
    Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment.
    We do not plan to open a second comment period, so anyone
interested in commenting should do so at this time. If we do not
receive adverse comments, no further activity is planned. For further
information, please see the direct final action.

    Dated: November 23, 2007.
Alexis Strauss,
Acting Regional Administrator, Region IX.
[FR Doc. E8-192 Filed 1-16-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: June 23, 2010 (Volume 75, Number 120)]
[Rules and Regulations]
[Page 35648-35649]
[DOCID:fr23jn10-14]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0530]

Safety Zones; Annual Fireworks Events in the Captain of the Port
Detroit Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zones for annual
fireworks events in the Captain of the Port Detroit zone from 9 p.m. on
June 23, 2010 through 11 p.m. on September 6, 2010. This action is
necessary and intended to ensure safety of life on the navigable waters
immediately prior to, during, and immediately after fireworks events.
Enforcement of the safety zones will establish restrictions upon, and
control movement of, vessels in a specified area immediately prior to,
during, and immediately after fireworks events. During the enforcement
periods, no person or vessel may enter the safety zone without
permission of the Captain of the Port.

DATES: The regulations will be enforced at various times from 9 p.m. on
June 23, 2010 through 11 p.m. on September 6, 2010.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail Commander Joseph Snowden, Prevention, U.S. Coast Guard
Sector Detroit, 110 Mount Elliot Ave., Detroit, MI 48207; telephone
313-568-9508, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    The Coast Guard will enforce the following safety zones, listed in
nineteen separate sections of 33 CFR 165.941, which were published in
the August 8, 2008 issue of the Federal Register (73 FR 46197):

Sec.  165.941(a)(30)  Bay-Rama Fishfly Festival Fireworks, New
Baltimore, MI.

    This regulation will be enforced from 9 p.m. to 11 p.m. on June 23,
2010; and from 9 p.m. to 11 p.m. on June 24, 2010. In the case of
inclement weather on June 23 or 24, 2010, this regulation will also be
enforced from 9 p.m. to 11 p.m. on June 25, 26, or 27, 2010, weather
permitting.

Sec.  165.941(a)(35)  City of Wyandotte Fireworks, Wyandotte, MI.

    This regulation will be enforced from 9:15 p.m. to 10:30 p.m. on
June 25, 2010.

Sec.  165.941(a)(40)  St. Clair Shores Fireworks, St. Clair Shores, MI.

    This regulation will be enforced from 10 p.m. to 11 p.m. on June
25, 2010. In the case of inclement weather on June 25, 2010, this
regulation will also be enforced from 10 p.m. to 11 p.m. on June 26,
2010.

Sec.  165.941(a)(8)  Harrisville Fireworks, Harrisville, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
3, 2010. In the case of inclement weather on July 3, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 4,
2010.

Sec.  165.941(a)(37)  Caseville Fireworks, Caseville, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
3, 2010. In the case of inclement weather on July 3, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 5,
2010.

Sec.  165.941(a)(43)  Lexington Independence Festival Fireworks,
Lexington, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
3, 2010. In the case of inclement weather on July 3, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 4,
2010.

Sec.  165.941(a)(38)  Algonac Pickerel Tournament Fireworks, Algonac,
MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
3, 2010. In the case of inclement weather on July 3, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 4,
2010.

Sec.  165.941(a)(36)  Grosse Point Farms Fireworks, Grosse Point Farms,
MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
3, 2010. In the case of inclement weather on July 3, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 4,
2010.

Sec.  165.941(a)(45)  Grosse Isle Yacht Club Fireworks, Grosse Isle,
MI.

    This regulation will be enforced from 9 p.m. to 11 p.m. on July 3,
2010. In the case of inclement weather on July 3, 2010, this regulation
will also be enforced from 9 p.m. to 11 p.m. on July 4, 2010.

Sec.  165.941(a)(48)  Tawas City 4th of July Fireworks, Tawas, MI.

    This regulation will be enforced from 9:30 p.m. until 11 p.m. on
July 4, 2010.

Sec.  165.941(a)(3)  Au Gres City Fireworks, Au Gres, MI.

    This regulation will be enforced from 9:30 p.m. until 11 p.m. on
July 4, 2010.

Sec.  165.941(a)(47)  Bell Maer Harbor 4th of July Fireworks, Harrison
Township, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
4, 2010. In the case of inclement weather on July 4, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 5,
2010.

Sec.  165.941(a)(32)  City of St. Clair Fireworks, St. Clair, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
4, 2010. In the case of inclement weather on July 4, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 5,
2010.

Sec.  165.941(a)(34)  Port Austin Fireworks, Port Austin, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
4, 2010. In the case of inclement weather on July 4, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 5,
2010.

Sec.  165.941(a)(46)  Trenton Fireworks, Trenton, MI.

    This regulation will be enforced from 10 p.m. to 11 p.m. on July 4,
2010. In the case of inclement weather on July 4, 2010, this regulation
will also be enforced from 10 p.m. to 11 p.m. on July 5, 2010.

Sec.  165.941(a)(7)  Gatzeros Fireworks, Grosse Point Park, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
4, 2010. In the case of inclement weather on July 4, 2010, this
regulation will also be enforced from 9:30 p.m. to 11 p.m. on July 5,
2010.

Sec.  165.941(a)(42)  Grosse Point Yacht Club 4th of July Fireworks,
Grosse Point Shores, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on July
4, 2010. In the case of inclement weather on July 4, 2010, this
regulation will also be

enforced from 9:30 p.m. to 11 p.m. on July 5, 2010.

Sec.  165.941(a)(10)  Trenton Rotary Roar on the River Fireworks,
Trenton, MI.

    This regulation will be enforced from 9:30 p.m. until 11 p.m. on
July 24, 2010.

Sec.  165.941(a)(13)  Detroit International Jazz Festival Fireworks,
Detroit, MI.

    This regulation will be enforced from 9:30 p.m. to 11 p.m. on
September 4, 2010. In the case of inclement weather on September 4,
2010, this regulation will also be enforced from 9:30 p.m. to 11 p.m.
on September 5, 2010 or September 6, 2010.
    Under the provisions of 33 CFR 165.23, entry into, transiting, or
anchoring within these safety zones is prohibited unless authorized by
the Captain of the Port Detroit or his designated representative.
Vessels that wish to transit through the safety zones may request
permission from the Captain of the Port Detroit. Requests must be made
in advance and approved by the Captain of Port before transits will be
authorized. Approvals will be granted on a case by case basis. The
Captain of the Port may be contacted via U.S. Coast Guard Sector
Detroit on channel 16, VHF-FM. The Coast Guard will give notice to the
public via a Broadcast to Mariners that the regulation is in effect.
This notice is issued under authority of 33 CFR 165.23 and 5 U.S.C. 552
(a). If the District Commander, Captain of the Port, or other official
authorized to do so, determines that the regulated area need not be
enforced for the full duration stated in this notice, he or she may use
a Broadcast Notice to Mariners to grant general permission to enter the
safety zone.

    Dated: June 11, 2010.
J.E. Ogden,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2010-15145 Filed 6-22-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 11 (Thursday, January 16, 2020)]
[Notices]
[Pages 2746-2747]
[FR Doc No: 2020-00592]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4752]

Pediatric Study Plans for Oncology Drugs: Questions and Answers;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Pediatric
Study Plans for Oncology Drugs: Questions and Answers.'' This draft
guidance provides information to sponsors regarding the submission of
an initial pediatric study plan (iPSP), as required by the Federal
Food, Drug, and Cosmetic Act (FD&C Act), for oncology drugs only.
Specifically, when finalized, this draft guidance will provide FDA's
current thinking regarding iPSPs for oncology drugs in light of the
amendments to the FD&C Act made by the FDA Reauthorization Act of 2017
(FDARA). FDA has received a number of questions on this topic and, as a
result, is providing this draft guidance in a question and answer
format, addressing the most frequently asked questions.

DATES: Submit either electronic or written comments on the draft
guidance by March 16, 2020 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-2019-D-4752 for ``Pediatric Study Plans for Oncology Drugs:
Questions and Answers.'' 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.
     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.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10001

New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002 or the Office of Communication, Outreach and Development,
Center for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Gregory Reaman, Oncology Center of
Excellence, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 2202, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pediatric Study Plans for Oncology Drugs: Questions and
Answers.'' This draft guidance provides information regarding the
submission of an iPSP, as required by section 505B(e) of the FD&C Act
(21 U.S.C. 355c(e)), for oncology drugs only. When finalized, this
draft guidance will provide FDA's current thinking regarding iPSPs for
oncology drugs in light of the amendments to section 505B of the FD&C
Act (also referred to as the Pediatric Research Equity Act, or PREA)
made by section 504 of FDARA (Pub. L. 115-52). This draft guidance does
not contain a complete discussion of general requirements for
development of drugs for pediatric use under PREA or section 505A of
the FD&C Act (21 U.S.C. 355a) (also referred to as the Best
Pharmaceuticals for Children Act or BPCA (Pub. L. 107-109)).
    Section 504 of FDARA amended section 505B of the FD&C Act to
require--for original applications submitted on or after August 18,
2020--pediatric investigations of certain targeted cancer drugs with
new active ingredients, based on molecular mechanism of action rather
than clinical indication. FDARA thus created a mechanism to require
evaluation of certain novel medicines that may have the potential to
address an unmet medical need in the pediatric population. Timely
investigation in children of the antitumor activity of potentially
effective targeted drugs under development in adults and of those
drugs' toxicities relative to the unique growth and developmental
considerations of pediatric patients, is intended to accelerate early
pediatric evaluation of these products and ultimately facilitate
development of appropriate new therapies for pediatric patients.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Pediatric
Study Plans for Oncology Drugs: Questions and Answers.'' It does 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. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in 21 CFR part 314 have been approved under
OMB control number 0910-0001. The collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: January 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00592 Filed 1-15-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 153 (Friday, August 7, 2020)]
[Notices]
[Pages 47956-47957]
[FR Doc No: 2020-17297]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2302-090]

Brookfield White Pine Hydro, LLC; Notice of Application for
Amendment of License, Soliciting Comments, Motions To Intervene, and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Proceeding: Application non-capacity amendment of
license.
    b. Project No.: 2302-095.
    c. Date Filed: April 21, 2020, and supplemented on June 3 and 8,
2020.
    d. Licensee: Brookfield White Pine Hydro, LLC.
    e. Name of Project: Lewiston Falls Hydroelectric Project.
    f. Location: The project is located on the Androscoggin River in
the town of Lewiston, Androscoggin County, Maine.
    g. Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Licensee Contact: Ms. Kelly Maloney, Manager, Compliance
Northeast, 150 Main Street, Lewiston, Maine 04240,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    i. FERC Contact: Christopher Chaney,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing comments, interventions, and protests is
September 2, 2020.
    The Commission strongly encourages electronic filing. Please file
motions to intervene, protests and comments using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>(866) 208-3676 (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include docket number P-2302-090.
    k. Description of Proceeding: The applicant proposes to modify the
project boundary to shorten the downstream extent of the project
boundary by approximately 5 miles. Currently, the boundary encloses
approximately 5.3 miles of the Androscoggin River downstream of the
project powerhouse. The revised boundary would enclose approximately
0.28 mile of the downstream river. There are no lands proposed to be
removed from the boundary. Additionally, the proposal does not include
any changes to current project features, operations, recreation
facilities, or public access, and it will have no impact on the
generating or water control capabilities.
    l. Filings may be viewed on the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-2302-
090) excluding the last three digits in the docket number field to
access the documents. You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of
new filings and issuances related to this or other pending projects.
For assistance, call 1-866-208-3676 or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.212 and .214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as
applicable; (2) set forth in the heading the name of the applicant and
the project number of the application to which the filing responds; (3)
furnish the name, address, and telephone number of the person
protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR

385.2001 through 385.2005. All comments, motions to intervene, or
protests must set forth their evidentiary basis. Any filing made by an
intervenor must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.

    Dated: August 3, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-17297 Filed 8-6-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21770-21771]
[FR Doc No: 2018-09964]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CD18-8-000]

Notice of Preliminary Determination of a Qualifying Conduit
Hydropower Facility and Soliciting Comments and Motions To Intervene:
Davis and Weber Counties Canal Company

    On April 27, 2018, Davis and Weber Counties Canal Company filed a
notice of intent to construct a qualifying conduit hydropower facility,
pursuant to section 30 of the Federal Power Act (FPA), as amended by
section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA).
The proposed West Point Pump Station Micro-hydropower Project would
have an installed capacity of 8 kilowatts (kW), and would be located
along Davis and Weber Counties Canal Company's secondary irrigation
system. The project would be located near the Town of West Point in
Davis County, Utah.
    Applicant Contact: Richard Smith, General Manager, Davis and Weber
Counties Canal Company, 138 West 1300 North, Sunset, UT 84015; Phone
No.<PHONE_NUMBER>.
    FERC Contact: Robert Bell, Phone No.<PHONE_NUMBER>; Email:
[email protected].
    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) Two new generating units that have a
total generating capacity of 8 kW, housed in a pump return pipeline to
a storage reservoir; and (2) appurtenant facilities. The proposed
project would have an estimated annual generation of 6 megawatt-hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

      Table 1--Criteria for Qualifying Conduit Hydropower Facility
------------------------------------------------------------------------
                                                            Satisfies (Y/
       Statutory provision               Description             N)
------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by    The conduit the facility            Y
 HREA.                             uses is a tunnel,
                                   canal, pipeline,
                                   aqueduct, flume, ditch,
                                   or similar manmade
                                   water conveyance that
                                   is operated for the
                                   distribution of water
                                   for agricultural,
                                   municipal, or
                                   industrial consumption
                                   and not primarily for
                                   the generation of
                                   electricity.
FPA 30(a)(3)(C)(i), as amended    The facility is                     Y
 by HREA.                          constructed, operated,
                                   or maintained for the
                                   generation of electric
                                   power and uses for such
                                   generation only the
                                   hydroelectric potential
                                   of a non-federally
                                   owned conduit.
FPA 30(a)(3)(C)(ii), as amended   The facility has an                 Y
 by HREA.                          installed capacity that
                                   does not exceed 5
                                   megawatts.
FPA 30(a)(3)(C)(iii), as amended  On or before August 9,              Y
 by HREA.                          2013, the facility is
                                   not licensed, or
                                   exempted from the
                                   licensing requirements
                                   of Part I of the FPA.
------------------------------------------------------------------------

    Preliminary Determination: The proposed hydroelectric project will
utilize an existing irrigation pipeline, the primary purpose of which
is to deliver lawn and garden pressure irrigation water to these same
counties to Davis and Weber Counties. The addition of the West Point
Pump Station Micro-hydropower Project will not alter the conduit's
primary purpose. Therefore, based upon the above criteria, Commission
staff preliminarily determines that the proposal satisfies the
requirements for a qualifying conduit hydropower facility, which is not
required to be licensed or exempted from licensing.
    Comments and Motions to Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All comments contesting
Commission staff's preliminary determination that the

facility meets the qualifying criteria must set forth their evidentiary
basis.
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    \1\ 18 CFR 385.2001-2005 (2017).
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    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at [email protected],<PHONE_NUMBER> (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE, Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (i.e., CD18-8) in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or email [email protected]. For TTY, call
(202) 502-8659.

    Dated: May 4, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-09964 Filed 5-9-18; 8:45 am]
BILLING CODE 6717-01-P


1 1. IDENTIFICATION OF THE INFORMATION COLLECTION ( a) This information collection request, which EPA is tracking under Information Collection Request ( ICR) 1910.02, covers the procedures for requesting information in response to Agency published synopses and/ or full or selected text of anticipated procurements and market research related to anticipated procurements. OMB control number is 2030 0039.

( b) The Office of Acquisition Management of the Environmental Protection Agency publishes synopses and/ or statements of work of upcoming Agency requirements in an effort to identify competent potential sources of supply. Likewise, the Office of Acquisition Management conducts market research through questions to the general public in an effort to identify alternative commercial supplies and services to fulfill Agency requirements and to identify competent potential sources of supply. The methods for publicizing contract actions are set forth in the Federal Acquisition Regulation ( FAR). FAR 5.201 and 5.205 set forth the individual circumstances when publication of a proposed contract action is either mandatory or desirable. FAR 10.001 sets forth the instances when market research is mandatory or desirable.

2. NEED FOR AND USE OF THE COLLECTION ( a) The legal authority for this collection is 15 U. S. C. 637( e) ( The Small Business Act), 41 U. S. C. 416 ( The Office of Federal Procurement Policy Act), and 41 U. S. C. 253. Collection of responses to Agency presolicitation requests for comments and information is essential to the Agency's mission. The procurement of contractor provided supplies and services, upon which the Agency relies, must begin with market research and fact finding conducted according to regulation. The contracting office constructs Requests for Proposals ( RFPs) and Invitations for Bids ( IFBs) based upon the findings in the presolicitation stage.

( b) Information obtained in response to synopses and market research is necessary to determine which sources will be solicited during the formal solicitation process. Information received may lead the Agency to set aside certain procurement actions exclusively for small and/ or small disadvantaged business concerns.

3. THE RESPONDENTS AND THE INFORMATION RECEIVED ( a) The respondents will normally be large and small businesses, profit making and nonprofit which are interested in selling their goods or services to the Agency. Typically, these respondents fall into one of the following Standard Industrial Classifications: 1629  dredging and surface cleanup activities, 3821  laboratory apparatus, 7379  computer related services, 8748  business consulting services, and 1542  construction services.

( b) FAR Parts 5 and 10 set forth the types of information requested in a synopsis or a market research inquiry respectively. This information collection request will discuss information requested in presolicitation publications and market research related activities that are not 2 specifically addressed in FAR clauses or certifications already cleared through the Office of Management and Budget ( OMB).

( c) The Office of Acquisition Management publishes synopses of anticipated requirements, statements of work, and other similar summary procurement notices, for the purpose of alerting the business community to upcoming federal contract opportunities, or to solicit comment from the same community on upcoming federal contract requirements. The comments solicited may be general or specific. Normally respondents will indicate their interest in being invited to participate in the competition for the contract and may be required to submit a capability statement. In order to submit the information requested, the respondent will have to gather available data from their internal records such as history of previous similar contracts. They may have to research and analyze company financial records.

( d) The Office of Acquisition Management conducts a form of market research which surveys the business community especially with respect to the commercial availability of supplies and services required by the Agency. Survey type questions addressing issues such as price, quantity, delivery schedule, current research and development efforts, future availability, etc. may also be included under the market research umbrella. Many market research efforts are conducted telephonically, and the respondent is required to draw upon his or her knowledge of the business operation to provide on the spot responses to specific questions. In other cases, market research is conduced in writing, typically through the survey method. In order to submit the information requested, the respondent will have to gather available data from their internal records such as history of previous similar contracts. They may have to research and analyze company financial records.

4. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT ( a) AGENCY ACTIVITIES:

( 1) The Agency activities in preparing the synopsis include the following tasks: identifying the requirement, preparing the specification or statement of work, determining the information to be collected, and preparing the publication notice.

( 2) The Agency activities in preparing a market research request include composing specific questions, determining the best forum for conducting the research, and, if required, preparing publication notices.

( 3) The data submitted by respondents will be reviewed by a contract specialist and, if required, a technical specialist. The data will be used to make subsequent procurement decisions which may include issues such as: what supply or service to procure, which sources to procure from, extent of small business set aside, type of contract vehicle, timing of solicitation, etc. 3 ( b) COLLECTION METHODOLOGY AND MANAGEMENT ( 1) The information is collected on a one time basis when the Agency has a requirement or anticipated requirement for supplies or services. Both synopses/ publicized requirements and market research are aimed toward respondents who are interested in providing products or services to the Government. Many respondents have a standard prepared capability statement, or prepared literature on products and services. Other responses to these requests for information will be prepared individually and tailored to the specific procurement or the specific question asked.

( 2) Submissions are accepted in any format so long as they include the requested data.

( 3) Submissions are voluntary. No one is required to respond to either a synopsis or publicized contract action, nor a request for information in connection with market research.

( c) SMALL ENTITY FLEXIBILITY ( 1) Separate or further simplified requirements for small entities are not practical, because the stated objectives cannot be met under such alternatives. All responses are voluntary, and the information collection is only the minimum necessary to ensure that the respondent has the potential capability to supply the Agency with goods or services.

5. NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA ( a) Information requested in a publicized, presolicitation contract action is unique to a specific procurement; this information cannot be obtained from any other source.

( b) To determine contractor burden associated with the information collection identified in this request, the following vendors were contacted:

Representative Firm Phone Mr. Kevin Cooley Resource Management Concepts ( 301) 862 7501 Mr. Thomas Walker Industrial Economics ( 617) 354 0074 Mr. Jack Pooley Igov. com ( 800) 777 9375 Ms. Kimberly Bradbury Veritas Software Corp. ( 800) 327 2232 Each individual consulted indicated that he/ she understood the need for the information collection and did not find the collection excessively burdensome. Estimated time to complete the information collection was considered in " Respondent Burden Estimate."

( c) Contract actions are publicized, and market research is initiated, only when the Agency has a need for a particular supply or service. Respondents only reply, or are only 4 solicited, if they are interested in selling products or services to the Government.

( d) This information is in accordance with the Office of Management and Budget's general guidelines for federal data collection.

( e) Information collected under this request, particularly cost and pricing data and contractor capability statements, is treated as Confidential Business Information ( CBI). This information is protected from public release in accordance with the Agency's confidentially regulation, 40 C. F. R. Part 2.201 et seq.

( f) Public Notice Required Prior to ICR Submission to OMB: The Federal Register document required under 5 CFR 1320.8( d), soliciting comments on this collection of information was published on July 5, 2002, 67 FR 44826. No comments were received.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION ( a) ESTIMATION OF RESPONDENT BURDEN ( 1) Labor costs Burden respondent estimates for this collection are divided into two categories: burden hours for responding to an synopsized procurement notice, and burden hours for responding to a request for information associated with market research. Synopses relate almost exclusively to major contracts, while market research frequently includes simplified acquisition procurements and/ or purchase orders. Both types of requests for information may vary widely in the amount of information they request, but generally, in the presolicitation stage, the questions are few, and the responses are not detailed. Requests for general comment are common.

Respondent Burden, Cost Estimate for Responses to Publicized Contract Actions Collection Activity Burden Hours Cost 1. Read/ research information requested 1 hour $ 89.32 2. Create/ gather information .5 hour $ 26.98 3. Compile review information .5 hour $ 44.66 4. Type response .5 hour $ 19.39 2.5 hours $ 180.35 Steps 1 and 3 of the information collection are completed by an administrative manager responsible for coordinating with the technical and financial personnel. Technicians, both financial 5 and scientific would be responsible for completing step 2, and clerical personnel would be responsible for completing step 4. The U. S. Department of Labor, Bureau of Labor Statistics, estimates loaded hourly labor rates for the labor categories involved to be as follows: administrative manager, $ 89.32; technician, $ 53.96; and typist $ 38.18. These rates have increased from those contained in the initial ICR issued in 1999 due to labor escalation. The estimated time to complete each step is based upon consultation with contractors and Agency contracting staff.

Based on the Agency's automated contract system, there have been 203 contracts awarded in FY 2002 through August. It is estimated that approximately 40 more contracts will be awarded by the end of the fiscal year. This will make a total of 243 contracts awarded in FY 2002. There have been 8,244 purchase orders awarded in FY 2002 through August. It is estimated that another 1,400 will be awarded by the end of the fiscal year. This will make a total of 9,644 purchase orders awarded in FY 2002. These figures were utilized to project burden estimates. These number have increased slightly since the initial ICR because they are based on historical actuals which fluctuate year to year.

It is estimated that 80% of future contracts will have some form of presolicitation publication whether it be a synopsis, a sources sought notice, or a request for comment on statement of work requirements. We estimate that less than 7.5% of purchase orders would have any type of presoliciation publication. Therefore, approximately 199 contracts and 723 purchase orders, or 922 total orders will be subject to presolicitation publication.

The Agency further estimates that an average of two ( 2) members of the public will respond to each notice, yielding 1,844 as the total number of respondents ( 922 total orders X 2 respondents = 1,844). With each response taking 2.5 hours to complete at an average cost of $ 180.35, the annual cost to respondents is $ 332,565.40 ( 1,844 respondents X $ 180.35 per response = $ 332,565.00) The total annual burden hour estimate for publicized contract actions is 4610 hours. ( 2.5 hours X 1,844 total responses = 4610 hours)

Respondent Burden, Cost Estimate for Responses to Market Research Inquiries Collection Activity Burden Hours Cost 1. Read or listen to information request .5 hour $ 44.66 2. Create/ gather information 1 hour $ 53.96 3. Compile review information .5 hour $ 44.66 4. Type response 1 hour $ 38.18 3 hours $ 181.46 6 Steps 1 and 3 of the information collection is completed by an administrative manager who is responsible for coordinating with the technical and financial personnel. Step 2 is completed by technicians, and step 4 is completed by clerical personnel. The U. S. Department of Labor, Bureau of Labor Statistics, estimates the loaded hourly labor rates for the personnel involved to be as follows: administrative manager, $ 89.32; technician $ 53.96; and typist, $ 38.18. The estimated time to complete each step is based upon consultation with contractors and Agency contracting staff.

Based upon the Agency's automated contract management system plus an estimate of contracts/ orders to be awarded through the end of FY 2002, 243 contracts will be awarded and 9,644 purchase order will be issued in FY 2002 for a total of 9, 877 procurements. Inasmuch as there are many methods of market research which do not require information collection clearance, the type of market research which would require clearance is not conducted on a large scale at EPA. That is, instances when an identical question is posed to 10 or more members of the public, is estimated to occur on fewer than 20% of Agency procurements ( 9,877 X 20% = 1976). Further, the Agency estimates that an average of two ( 2) respondents will reply to each market research notice. Therefore, total annual burden hours are estimated at 3,951 ( 20% of 9,877= 3,951), times two respondents per notice ( 3,951 X 2 = 7,902), times three hours per response ( 7,902 respondents X 3 = 23, 706) equals 23,706 hours. The average annual cost to respondents is $ 1,433,897.00 ( 7,902 respondents X $ 181.46 per response).

The bottom line total annual burden hours for respondents is 9,746 ( 1,844 respondents for publicized contract actions plus 7,902 respondents for market research equals 9,746 respondents total). The bottom line annual costs for respondents is $ 1,766,462 ($ 332,565.40 for publicized contract actions plus $ 1,433,897.00 for market research inquiries equals $ 1,766,462 in annual costs for respondents).

( 2) Capital/ Start up Costs Because it will not be necessary for respondents to acquire any capital goods to provide the requested information, EPA has not included any estimated capital costs.

( 3) Operating and Maintenance Costs Operating and maintenance costs, which include such items as file storage, photocopying, and postage, are negligible.

( 4) Bottom Line Burden Hours and Costs for Respondents Total Annual Hours for Publicized Contract Actions plus Market Research Inquiries: 28,316 hours ( 4,610 + 23,706) 7 Total Annual Costs for Publicized Contract Actions plus Market Research Inquiries: $ 1,766,462.00 ($ 332,565.40 + $ 1,433,897.00).

( b) ESTIMATING AGENCY BURDEN AND COST Agency burden for responses to publicized contract action and market research information is presented in one analysis, as the actions and time required for evaluation of each are basically identical.

Agency Burden, Cost Estimate Collection Activity Burden Hours Cost 1. Develop synopsis/ notice, 3 hour $ 110.79 Develop market research questions 2. Distribution 2 hour $ 73.86 3. Review data received 3 hour $ 110.79 8 hour $ 295.44 Synopses and market research questions are developed jointly by the contract specialist and program manager. This effort is estimated to be at the GS  13 level. The estimate includes GS 13 salary at $ 31.84 per hour, multiplied by a factor of 1.16 to reflect benefits, which yields a loaded rate of $ 36.93. This rate has increase since the initial ICR due to labor escalation. Distribution and review of data received is performed mainly by the contract specialist, and is again estimated using the loaded rate for a GS 13.

Average Agency burden is estimated at 8 hours per occupancy times an hourly rate of $ 36.93 for a total of $ 295.44. Based on total annual projections of 922 occurrences of publicized actions, and 1976 occurrences of qualifying market research activity, annual Agency burden is estimated at $ 856,185. The total annual burden hours are 23,184 ( 8 hours per action x 2898 actions).

7. BURDEN STATEMENT Public reporting for this collection of information is estimated to average 2.75 hours per response which includes the time for reviewing the request, searching existing data sources, gathering and maintaining the information requested, and responding. Burden time 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, to develop, acquire, install and utilize technology and systems for the purpose of 8 collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to adjust the existing ways to comply with any previously applicable instructions and requirements; to train personnel to be able to respond to a collection of information; to search the data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. 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 number for EPA's regulations are listed in 40 CFR Part 9, and 48 CFR Chapter 15.

Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U. S. Environmental Protection Agency ( 2822), 1200 Pennsylvania Avenue., NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number 1910.02 and OMB control number 2030 0039 in any correspondence.


[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43535-43536]
[FR Doc No: 2017-19727]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER17-2109-001.
    Applicants: PJM Interconnection, L.L.C., Old Dominion Electric
Cooperative.
    Description: Compliance filing: Compliance Filing per 8/31/17 Order
in Docket No. ER17-2109-000 to be effective 7/1/2017.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5034.
    Comments Due: 5 p.m. ET 10/3/17.

    Docket Numbers: ER17-2456-000.
    Applicants: Ohio Power Company.
    Description: Sec.  205(d) Rate Filing: OPCo-Fremont Energy Center
Facilities Agreement Cancellation to be effective 9/30/2017.
    Filed Date: 9/11/17.
    Accession Number: 20170911-5101.
    Comments Due: 5 p.m. ET 10/2/17.

    Docket Numbers: ER17-2457-000.
    Applicants: Rock Creek Wind Project, LLC.
    Description: Baseline eTariff Filing: MBR Tariff to be effective 9/
15/2017.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5031.
    Comments Due: 5 p.m. ET 10/3/17.

    Docket Numbers: ER17-2458-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 20170911_Yampa Valley 2nd
Amended Cleanup Filing to be effective 4/28/2017.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5086.

    Comments Due: 5 p.m. ET 10/3/17.

    Docket Numbers: ER17-2459-000.
    Applicants: American Transmission Systems, Incorporation, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI Submits Engineering and
Construction Services Agreement No. 4712 to be effective 11/11/2017.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5089.
    Comments Due: 5 p.m. ET 10/3/17.

    Docket Numbers: ER17-2460-000.
    Applicants: Public Service Company of Colorado.
    Description: Sec.  205(d) Rate Filing: 20170911_IREA 4th Amended
Cleanup Filing to be effective 4/28/2017.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5092.
    Comments Due: 5 p.m. ET 10/3/17.

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

    Docket Numbers: ES17-25-000; ES17-26-000; ES17-27-000; ES17-28-000;
ES17-29-000; ES17-30-000.
    Applicants: Entergy Arkansas, Inc., Entergy Louisiana, LLC, Entergy
Mississippi, Inc., Entergy New Orleans, Inc., Entergy Texas, Inc.,
System Energy Resources, Inc.
    Description: Supplement to April 28, 2017 Joint Application for
Authorizations under FPA Section 204 of Entergy Arkansas, Inc., et al.
    Filed Date: 9/1/17.
    Accession Number: 20170901-5232.
    Comments Due: 5 p.m. ET 9/22/17.

    Docket Numbers: ES17-56-000.
    Applicants: Georgia Power Company.
    Description: Application for Borrowing Authority of Georgia Power
Company.
    Filed Date: 9/12/17.
    Accession Number: 20170912-5069.
    Comments Due: 5 p.m. ET 10/3/17.

    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: September 12, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-19727 Filed 9-15-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 10, 2006 (Volume 71, Number 154)]
[Notices]
[Page 45811]
[DOCID:fr10au06-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-457-000]

Transcontinental Gas Pipe Line Corporation; Notice of Tariff
Filing

August 3, 2006.
    Take notice that on August 1, 2006, Transcontinental Gas Pipe Line
Corporation (Transco) tendered for filing as part of its FERC Gas
Tariff, Third Revised Volume No. 1, the tariff sheets listed on
Appendix A to its filing, to become effective July 1, 2006. The revised
tariff sheets reflect the cancellation of Rate Schedule FT-NT and make
additional conforming changes.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-13077 Filed 8-9-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 36 (Wednesday, February 23, 2011)]
[Notices]
[Pages 10024-10025]
[FR Doc No: 2011-4006]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2010-0690; FRL-9270-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; EPA's Light-Duty In-Use Vehicle
and Engine Testing Program (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before March 25,
2011.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2010-0690, to (1) EPA online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Air and Radiation Docket, Mailcode 28221T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Lynn Sohacki, Compliance and
Innovative Strategies Division, Office of Transportation and Air
Quality, Environmental Protection Agency, 2000 Traverwood, Ann Arbor,
Michigan 48105; telephone number:<PHONE_NUMBER>; fax number: 734-214-
4869; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On August 25, 2010 (75 FR 52326), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2010-0690, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and
Radiation Docket in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 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<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://www.regulations.gov.
    Title: EPA's In-Use Vehicle and Engine Testing Programs (Renewal)
    ICR numbers: EPA ICR No. 0222.09, OMB Control No. 2060-0086.
    ICR Status: This ICR is scheduled to expire on February 28, 2010.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
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
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: EPA has an ongoing program to evaluate the emission
performance of in-use light-duty (passenger car and light truck) motor
vehicles. This program operates in conjunction with testing of
prototype vehicles prior to use (manufacturer and EPA confirmatory
testing for certification) and the mandatory manufacturer's in-use
testing program (IUVP) for light-duty vehicles. They derive from the
Clean Air Act's charge that EPA insure that motor vehicles comply with
emissions requirements throughout their useful lives. The primary
purpose of the program is information gathering. Nevertheless, EPA can
require a recall if it receives information, from whatever source,
including in-use testing, that a ``substantial number'' of any class or
category of vehicles or engines, although properly maintained and used,
do not conform to the emission standards, when in actual use throughout
their useful life.
    The program can be broken down into three closely-related headings.
The first is a surveillance program that selects approximately 50
classes of passenger cars and light trucks for in-use testing, at EPA's
testing facility, totaling approximately 150 vehicles (three in each
class on average). In rare cases surveillance testing may be followed
by compliance testing (only four such classes in the last five years).
The purpose of a compliance phase is to develop additional information
related to test failures observed in a class during surveillance
testing. The second heading is testing of a subset of approximately 35
vehicles from the surveillance recruitment for operation of on-board
diagnostics (OBD) systems. The third category is special investigations
involving testing of vehicles to address specific issues. The number of
vehicles procured under this category varies widely from year to year,
but this request asks for approval of the information burden
corresponding to 25 such vehicles per year for the next three years.
    Participation in the light-duty surveys, as well as the vehicle
testing, is strictly voluntary. A group of 25 to 50 potential
participants is identified from state vehicle registration records.
They are asked to return a postcard indicating their willingness to
participate and if so, to verify some limited vehicle information.
Three of those who return the card are called and asked about a half
dozen questions concerning vehicle condition, and operation and
maintenance. Additional groups of potential participants may be
contacted until a sufficient number of vehicles has been obtained.
Owners verify the survey information when they deliver their vehicles
to EPA, voluntarily provide maintenance records for copying, and
receive a loaner car and/or a cash incentive.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average less
than one hour

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 which have subsequently changed; 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: Individual and fleet owners of motor
vehicles and engines.
    Estimated Number of Respondents: Approximately 4,285 owners/lessees
receive EPA's solicitations to participate and approximately 164 do
participate.
    Frequency of Response: On Occasion.
    Estimated Total Annual Hour Burden: 521.
    Estimated Total Annual Cost: $11,295, including $0 annualized
capital or O&M costs.
    Changes in the Estimates: There is a decrease of 90 responses and
98 hours in the total estimated respondent burden compared with that
identified in the ICR currently approved by OMB. This decrease is
entirely due to removal of the heavy-duty and non-road portions of this
ICR, which will henceforth be covered under a different information
collection request (OMB Control Number 2060-0287).

    Dated: February 16, 2011.
John Moses,
Director, Collection Strategies Division.
[FR Doc. 2011-4006 Filed 2-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19101-19102]
[FR Doc No: 2014-07657]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2012-E-0490]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MELAFIND SYSTEM

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for MELAFIND SYSTEM and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (half
the testing phase must be subtracted as well as any time that may have
occurred before the patent was issued), FDA's determination of the
length of a regulatory review period for a medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
    FDA has approved for marketing the medical device MELAFIND SYSTEM.
MELAFIND SYSTEM is indicated for use on clinically atypical cutaneous
pigmented lesions with one or more clinical or historical
characteristics of melanoma, excluding those with a clinical diagnosis
of melanoma or likely melanoma. Subsequent to this approval, the Patent
and Trademark Office received a patent term restoration application for
MELAFIND SYSTEM (U.S. Patent No. 6,208,749) from MELA Sciences Inc.,
and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 10, 2012, FDA advised the Patent and Trademark
Office that this medical device had undergone a regulatory review
period and that the approval of MELAFIND SYSTEM represented the first
permitted commercial marketing or use of the product. Thereafter, the
Patent and Trademark Office requested that the FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
MELAFIND SYSTEM is 3,837 days. Of this time, 2,961 days occurred during
the testing phase of the regulatory review period, while 876 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective, or, if an investigational device
exemption (IDE) was not required, but institutional review board (IRB)
approval is required, under section 520(g)(3) of the FD&C Act, the IRB
approval date: May 2, 2001. The applicant claims there was no IDE
submitted under section 520(g) of the FD&C Act and claims the date that
IRB-required approval was effective was May 2, 2001. FDA concurs that
no IDE was submitted and that the IRB approval action was enacted May
2, 2001, according to the certificate of approval substantiating IRB
approval date provided in the application for patent term extension.
    2. The date an application was initially submitted with respect to
the device under section 515 of the the FD&C Act (21 U.S.C. 360e): June
9, 2009. FDA has verified the applicant's claim that the premarket
approval application (PMA) for MELAFIND SYSTEM (PMA P090012) was
initially submitted June 9, 2009.
    3. The date the application was approved: November 1, 2011. FDA has
verified the applicant's claim that PMA P090012 was approved on
November 1, 2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 2,355 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 6, 2014. Furthermore, any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period
by October 6, 2014. To meet its burden, the petition must contain
sufficient facts to

merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d
sess., pp. 41-42, 1984.) Petitions should be in the format specified in
21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07657 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Notices]
[Page 2121]
[FR Doc No: 2020-00388]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15021-000]

Bard College, New York; Notice of Application Tendered for Filing
With the Commission and Soliciting Additional Study Requests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Exemption from Licensing.
    b. Project No.: 15021-000.
    c. Date Filed: December 23, 2019.
    d. Applicant: Bard College, New York.
    e. Name of Project: Annandale Micro Hydropower Project.
    f. Location: On Saw Kill, a tributary of the Hudson River, in the
Town of Red Hook, Dutchess County, New York. The project does not
occupy federal land.
    g. Filed Pursuant to: Public Utility Regulatory Policies Act of
1978, 16 U.S.C. 2705, 2708 (2018), amended by the Hydropower Regulatory
Efficiency Act of 2013, Public Law 113-23, 127 Stat. 493 (2013).
    h. Applicant Contact: Randy Clum, Director, Buildings and Grounds,
Bard College, 30 Campus Road, Annandale-on-Hudson, NY 12504; and/or
Joel Herm/Jan Borchert, Current Hydro, Inc., P.O. Box 224, Rhinebeck,
NY 12572.
    i. FERC Contact: Monir Chowdhury at<PHONE_NUMBER>; or email at
<EMAIL_ADDRESS>    j. Cooperating agencies: Federal, state, local, and tribal agencies
with jurisdiction and/or special expertise with respect to
environmental issues that wish to cooperate in the preparation of the
environmental document should follow the instructions for filing such
requests described in item l below. Cooperating agencies should note
the Commission's policy that agencies that cooperate in the preparation
of the environmental document cannot also intervene. See, 94 FERC ]
61,076 (2001).
    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's
regulations, if any resource agency, Indian Tribe, or person believes
that an additional scientific study should be conducted in order to
form an adequate factual basis for a complete analysis of the
application on its merit, the resource agency, Indian Tribe, or person
must file a request for a study with the Commission not later than 60
days from the date of filing of the application, and serve a copy of
the request on the applicant.
    l. Deadline for filing additional study requests and requests for
cooperating agency status: March 9, 2020.
    The Commission strongly encourages electronic filing. Please file
additional study requests and requests for cooperating agency status
using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202)
502-8659 (TTY). In lieu of electronic filing, please send a paper copy
to: Secretary, Federal Energy Regulatory Commission, 888 First Street
NE, Washington, DC 20426. The first page of any filing should include
docket number P-15021-000.
    m. This application is not ready for environmental analysis at this
time.
    n. The proposed project would consist of: (1) An existing 240-foot-
long dam that impounds a 3-acre reservoir; (2) three new 6-foot-
diameter, 9.5-foot-high concrete cylindrical tanks, each housing a 4-
kilowatt gravitational vortex turbine-generator unit; (3) a new 240-
volt, 60-foot-long transmission line; and (4) appurtenant facilities.
The project is estimated to generate an average of 61 megawatt-hours
annually. The applicant proposes to operate the project in a run-of-
river mode.
    o. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    p. Procedural schedule and final amendments: The application will
be processed according to the following preliminary schedule. Revisions
to the schedule will be made as appropriate (e.g., if there are no
deficiencies or a need for additional information, the schedule would
be shortened).

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

------------------------------------------------------------------------
Issue Notice of Acceptance................  March 2020.
Issue Scoping Document 1 for comments.....  April 2020.
Comments on Scoping Document 1............  May 2020.
Issue Scoping Document 2 (if necessary)...  June 2020.
Issue Notice of Ready for Environmental     June 2020.
 Analysis.
Commission issues EA......................  December 2020.
------------------------------------------------------------------------

    Dated: January 8, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-00388 Filed 1-13-20; 8:45 am]
BILLING CODE 6717-01-P


                                  MEMORANDUM

Tetra Tech, Inc.
10306 Eaton Place, Suite 340
Fairfax, VA 22030
phone<PHONE_NUMBER>
fax<PHONE_NUMBER>

TO:			Record
FROM:		Kelly Meadows
DATE: 		February 24, 2011

SUBJECT:	Organism densities by waterbody type

The following document presents information on the density of organisms in various waterbody types.  Attachment A shows that impingement and entrainment (on a volumetric basis) is present in all waterbody types in similar concentrations.


[Federal Register Volume 88, Number 240 (Friday, December 15, 2023)]
[Notices]
[Page 87046]
[FR Doc No: 2023-27501]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2023-25488]

Random Drug and Alcohol Testing Percentage Rates of Covered
Aviation Employees for the Period January 1, 2024 to December 31, 2024;
Correction

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Random drug and alcohol testing percentage rates of covered
aviation employees for the period January 1, 2024 to December 31, 2024;
correction.

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

SUMMARY: On November 17, 2023, the Federal Aviation Administration
(FAA) published the Random Drug and Alcohol Testing Percentage Rates of
Covered Aviation Employees for the Period January 1, 2024 to December
31, 2024. In that document, the FAA inadvertently provided incorrect
years in the supplementary information section. This document corrects
that error.

DATES: This correction is effective December 15, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Vicky Dunne, Federal Aviation
Administration, Office of Aerospace Medicine, Drug Abatement Division,
Program Policy Branch; Email [email protected]; Telephone (202)
267-8442.

SUPPLEMENTARY INFORMATION: On November 17, 2023, the Federal Aviation
Administration (FAA) published the Random Drug and Alcohol Testing
Percentage Rates of Covered Aviation Employees for the Period January
1, 2024 to December 31, 2024; Corrections. In the second column, third
paragraph under the supplementary section of the document, the year
appeared as 2023 instead of 2024. In the third column, first paragraph
under the supplementary section of the document, the year appeared as
2022 instead of 2024. This document corrects that error.

Corrections

    In the Federal Register of November 17, 2023, in FR Doc. 2023-
25488, on page 80376, in the second column, the year 2023 in the
thirty-first line in the SUPPLEMENTARY INFORMATION section should be
2024.
    In the Federal Register of November 17, 2023, in FR Doc. 2023-
25488, on page 80376, in the third column, the year 2022 in the third
line in the SUPPLEMENTARY INFORMATION section should be 2024.

Docket No. FAA-2023-25488

    Issued in Washington, DC.
Virginia Lozada,
Acting Director, Drug Abatement Division.
[FR Doc. 2023-27501 Filed 12-14-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 97 (Monday, May 22, 2017)]
[Notices]
[Pages 23240-23241]
[FR Doc No: 2017-10371]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14831-000]

Merchant Hydro Developers, LLC; Notice of Preliminary Permit
Application Accepted for Filing And Soliciting Comments, Motions To
Intervene, and Competing Applications

    On January 18, 2017, Merchant Hydro Developers, LLC, filed an
application for a preliminary permit, pursuant to section 4(f) of the
Federal Power Act (FPA), proposing to study the feasibility of the
Savage Mountain Pumped Storage Hydroelectric Project to be located in
Allegany County, Maryland. The sole purpose of a preliminary permit, if
issued, is to grant the permit holder priority to file a license
application during the permit term. A preliminary permit does not
authorize the permit holder to perform any land-disturbing activities
or otherwise enter upon lands or waters owned by others without the
owners' express permission.
    The proposed project would consist of the following: (1) A new
upper reservoir with a surface area of 75 acres and a storage capacity
of 1,125 acre-feet at a surface elevation of approximately 2,800 feet
above mean sea level (msl) created through construction of a new
roller-compacted concrete or rock-filled dam and/or dike; (2)
excavating a new lower reservoir with a surface area of 50 acres and a
total storage capacity of 1,350 acre-feet at a surface elevation of
1,820 feet msl; (3) a new 6,762-foot-long, 48-inch-diameter penstock
connecting the upper and lower reservoirs; (4) a new 150-foot-long, 50-
foot-wide powerhouse containing two turbine-generator units with a
total rated capacity of 90 megawatts; (5) a new transmission line
connecting the powerhouse to a nearby electric grid interconnection
point at the Savage Mountain Wind Farm; and (6) appurtenant facilities.
Possible initial fill water and make-up water would come from the
nearby Casselman River, including groundwater. The proposed project
would have an annual generation of 329,908 megawatt-hours.
    Applicant Contact: Adam Rousselle, Merchant Hydro Developers, LLC,
5710 Oak Crest Drive, Doylestown, PA 18902; phone:<PHONE_NUMBER>.
    FERC Contact: Monir Chowdhury; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of

intent must meet the requirements of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-14831-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14831) in the docket number field to access
the document. For assistance, contact FERC Online Support.

    Dated: May 15, 2017.
 Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-10371 Filed 5-19-17; 8:45 am]
 BILLING CODE 6717-01-P