[Federal Register Volume 76, Number 21 (Tuesday, February 1, 2011)]
[Notices]
[Page 5584]
[FR Doc No: 2011-2138]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13944-000]

Valley Affordable Housing Corporation; Notice of Preliminary
Permit Application Accepted for Filing and Soliciting Comments, Motions
To Intervene, and Competing Applications

January 21, 2011.
    On December 10, 2010, the Valley Affordable Housing Corporation
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 Manville Hydroelectric Project to be located at the Manville Dam,
on the Blackstone River, in Providence County, Rhode Island. 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: (1) The existing 22-foot-
high, 260-foot-long Manville Dam with one-foot flashboards owned by the
Town of Cumberland; (2) an existing 76-acre impoundment with a normal
water surface elevation of 106 feet (National Geodetic Vertical Datum
1929); (3) a new trashrack and stoplogs; (4) a new approximately 60-
foot-wide intake in place of a 60-foot-long section of the spillway
that would be removed; (5) new 10-foot-long, 12-foot-wide dual concrete
penstocks; (6) a new 30-foot-tall (extending 20 feet above the
spillway), 60-foot-wide powerhouse adjacent to the training walls; (7)
a new 25-foot-wide, 5-foot-deep crest gate adjacent to the powerhouse;
(8) two new bulb Kaplan turbines with a combined installed capacity of
1,026 kilowatts; (9) a new approximately 800-foot-long, 480-volt
transmission line; and (10) appurtenant facilities. The project would
have an estimated annual generation of 4,221 megawatt-hours.
    Applicant Contact: Peter Bouchard, Valley Affordable Housing
Corporation, 895 Mendon Road, Cumberland, RI 02864; phone: (401) 334-
2802.
    FERC Contact: Brandon Cherry; 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. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site 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>or toll free at 1-866-208-3676,
or for TTY,<PHONE_NUMBER>. Although the Commission strongly encourages
electronic filing, documents may also be paper-filed. To paper-file,
mail an original and seven copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at  http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13944) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2011-2138 Filed 1-31-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Page 38151]
[FR Doc No: 2020-13280]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2020-0002]

Final Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security (DHS).

ACTION: Notice; withdrawal.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its final notice concerning the flood hazard determinations for Bristol
County, Massachusetts (All Jurisdictions).

DATES: The final notice concerning the flood hazard determinations for
Bristol County, Massachusetts (All Jurisdictions) published June 1,
2020 (85 FR 33175) is withdrawn as of June 25, 2020.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 1, 2020, FEMA published a notice at
85 FR 33176, containing final flood hazard determinations for Bristol
County, Massachusetts (All Jurisdictions). Communities within the Cape
Cod Watershed study experienced difficulties during the adoption and
compliance period resulting in the inability to adopt the FIS and FIRM
and thereby comply with the National Flood Insurance Program (NFIP)
regulations. The final flood hazard determinations is hereby rescinded,
and ordinances must revert to the previously adopted FIS Report and
FIRM. FEMA is withdrawing the notice for the affected communities.

    Authority: 42 U.S.C. 4104; 44 CFR 67.4.

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2020-13280 Filed 6-24-20; 8:45 am]
BILLING CODE 9111-23-P


176
product after approval?
177
No, it does not matter if the sponsor decides not to market the product.  Eligibility will be based
178
on the criteria outlined in the statute.
179
180
Q7.
What form will the voucher take?
181
182
The FDA will include information related to the priority review voucher in the approval letter for
183
the tropical disease drug application.
184
185
Q8.
Will these vouchers be transferable?
186
187
Yes, by the sponsor receiving the voucher.  As the statute states (section 524(b)(2)), the tropical
188
disease product sponsor receiving a tropical disease priority review voucher may transfer the
189
entitlement to such voucher (including by sale) to another sponsor of a human drug application.
190
The language of the statute allows for one transfer from the original recipient of the voucher to
191
another sponsor of a human drug for which an application under section 505(b)(1) of the Act or
192
section 351 of the PHS Act will be submitted after the date of the approval of the tropical disease
193
product application.  Although the statute’s language imposes a limitation of one actual transfer
194
of the voucher, FDA believes that contractual arrangements such as the use of an option or
195
transfer of the right to designate the voucher’s recipient could comply with the terms of the
196
statute.
197
198
Q9.
What is the procedure for voucher transfer?
199
200
The transfer should be documented with a letter of transfer from the tropical disease application
201
holder granted the voucher and a letter from the new voucher owner acknowledging the transfer.
202
These letters should be included in the application for which the sponsor wishes to redeem the
203
priority review voucher.  A voucher cannot be redeemed unless a complete record of transfer is
204
available to the Agency.
205
206
Q10.  When can a voucher be used?
207
208
After the voucher is issued, the sponsor redeeming the voucher must notify FDA of their intent
209
to submit a human drug application with a priority review voucher at least 365 days prior to
210
submission of the human drug application for which a priority review voucher will be used to
211
obtain a priority review.  The notification must include the date the sponsor intends to submit the
212
application.  In accordance with the language of the statute, FDA will consider this notification
213
as a legally binding commitment to pay the priority review user fee for the fiscal year in which
214
the application is submitted.
215

Contains Nonbinding Recommendations
Draft — Not for Implementation
6
216
217
Q11.  What fees apply when using a priority review voucher?
218
219
The sponsor of a human drug application that is the subject of a priority review voucher must
220
pay FDA a priority review user fee in addition to any other fee required under the prescription
221
drug user fee program.  As the statute requires, the amount of the priority review user fee will be
222
determined each fiscal year and based on the average cost incurred by FDA in the review of a
223
human drug application subject to priority review in the previous fiscal year.
224
225
FDA will establish the fee amount before the beginning of each fiscal year and will publish the
226
fee schedule in the Federal Register.
227
228
Q12.  When do I pay the priority review voucher fee?
229
230
According to the terms of the statute, the priority review user fee is due upon submission of the
231
application for which the priority review voucher is used.  The statute specifies that the
232
application will be considered incomplete if the priority fee and all other applicable user fees are
233
not paid in accordance with FDA payment procedures.  In addition, FDA cannot collect these
234
fees in any fiscal year until Congress has passed a law appropriating funds for these fees.
235
Because FDA may not grant a waiver, exemption, reduction, or refund of any fees due and
236
payable under this section of the Act and FDA may not collect priority review voucher fees prior
237
to a relevant appropriation for that fiscal year, FDA cannot accept any application using a
238
priority review voucher if the necessary appropriation has not become law for that fiscal year.
239
240
Q13.  If I present a voucher to FDA for priority review, am I guaranteed a 6-month
241
review on my new drug application?
242
243
No.  The definition of priority review in section 524(a)(1) refers to the CDER MAPP and the
244
PDUFA goals letter.
6
We believe the intent of this section is that drugs for which priority review
245
vouchers are used should be treated as if they were any other priority review drug.  Therefore,
246
these applications would be placed in the priority review group.  The Agency has committed to a
247
goal of completing 90 percent of priority reviews within 6 months.
248
249
Q14.  Can FDA determine whether an application will be eligible to receive a voucher
250
before an application is approved or licensed (i.e., prior to NDA/BLA submission or
251
during review of the application)?
252
253
No.  It is important to note that a product that meets the criteria at the time of submission may
254
not meet those same criteria at the time of the approval action and would thus not be eligible to
255
receive a priority review voucher. This could occur if another application containing the same
256
active ingredient is approved first.  For this reason, the Agency will not make voucher
257
determinations until the time of application approval.
258
259
Q15.  Are combination products eligible for priority review vouchers?
260
6
The PDUFA goals can be found on the Internet at http://www.fda.gov/oc/pdufa4/pdufa4goals.html.

Contains Nonbinding Recommendations
Draft — Not for Implementation
7
261
It depends.  A combination product is eligible if the product, including all active ingredients,
262
meets the criteria established in FDAAA.  However, if the product contains any active ingredient
263
that has been previously approved, the application is not eligible for a priority voucher (see
264
section 524(a)(4)(C) of the Act).
265
266
Q16.  Are products eligible that have been approved and used in other countries but have
267
not previously been submitted for review by the FDA?
268
269
Yes, as long as they meet all the elements for a tropical disease product application described in
270
section 524(a)(4).
271
272
Q17.  Is a drug that is already approved for another indication eligible for a priority
273
review voucher for a tropical disease application?
274
275
No.  For an application to qualify, it must be for a human drug, no active ingredient (including
276
any ester or salt of the active ingredient) of which has been approved in any other application
277
under section 505(b)(1) of the Act or section 351 of the PHS Act.
278
279
Q18.  Would a new pediatric formulation for a drug already approved for adults be
280
eligible?
281
282
No.  As noted above, an application for a product containing a previously approved drug is not
283
eligible to receive a tropical disease priority voucher.
284
285
Q19.  Would an application for a tropical disease product submitted to FDA prior to
286
enactment of the statute but not yet approved qualify for a voucher?
287
288
No.  The tropical disease product sponsor may not receive a tropical disease priority voucher if
289
the application was submitted to the FDA before the date of the enactment of section 524
290
(September 27, 2007).
291
292
Q20.  Through what mechanism should a sponsor notify FDA that it intends to submit an
293
application eligible to receive a voucher?
294
295
The original submission of the tropical disease application should include the sponsor’s request
296
outlining how they meet the eligibility criteria for a priority review voucher.  We encourage early
297
communication with the review division in which these issues could be discussed; however,
298
notification before submission of the tropical disease application is not required.
299
300
Q21.  Could a tropical disease product also qualify as an orphan drug?
301
302
It is likely that a drug product meeting the requirements of section 524 will also qualify for
303
marketing exclusivity, tax credits, fee exemptions, and orphan product grants provided under the
304
Orphan Drug Act.  For information regarding these incentives, potential sponsors should contact
305
the Office of Orphan Products Development (OOPD).  These products may also qualify for new
306

Contains Nonbinding Recommendations
Draft — Not for Implementation
8
chemical entity marketing exclusivity provided under the Act.  For information regarding new
307
chemical entity marketing exclusivity, potential sponsors should contact the appropriate CDER
308
review division.
309
310
Q22.  What are the different roles played by CDER, CBER, and the Office of Orphan
311
Products Development?
312
313
CDER and CBER
314
315
The review divisions within the Center for Drug Evaluation and Research and the Center for
316
Biologics Evaluation and Research have the responsibility for premarket review of the tropical
317
disease product applications and for determining whether an application meets the eligibility
318
criteria for receiving a priority review voucher.
319
320
Office of Orphan Products Development
321
322
The Office of Orphan Products Development is located within the Office of the Commissioner
323
and is responsible for determining whether a drug or biologic qualifies for orphan drug status.
324
For example, to secure orphan status for the treatment of a rare disease, a sponsor demonstrates
325
to OOPD that the disease or condition is rare in the United States (i.e., <200,000 persons in the
326
United States are currently affected) and that the drug is expected to be effective (i.e., is
327
promising) in the treatment of the disease.  Orphan-drug designation must be granted prior to the
328
submission of a marketing application.  This is a separate process from the determination of
329
whether a drug or biologic will qualify as a tropical disease drug or will ultimately be eligible for
330
a voucher under the provisions of section 524.  The latter determination will be made by CDER
331
or CBER, as appropriate.
332
333
If the product meets the criteria of the Orphan Drug Act, OOPD will provide orphan designation
334
that qualifies the sponsor of the product for a tax credit and the marketing incentives of the
335
Orphan Drug Act.
7
Questions concerning orphan drug designations, or the benefits and
336
requirements associated with such designations, should be directed to OODP
337
(http://www.fda.gov/orphan)
.
338
339
Q23.  Does FDA plan to add other infectious diseases to the list?  If so, when can we expect
340
to see that?
341
342
Section 524 allows FDA to designate by regulation any other infectious disease for which there
343
is no significant market in developed nations and that disproportionately affects poor and
344
marginalized populations.  FDA intends to seek public input regarding the criteria that could be
345
used to designate other diseases as well as specific diseases that might meet those criteria.
346
347
Q24.  What should I do if I have other questions about a tropical disease application?
348
349
Sponsors with questions not addressed in this guidance should contact the appropriate review
350
division within the Center for Drug Evaluation and Research (CDER) or Center for Biologics
351
7
Information on the Orphan Drug Act is available at http://www.fda.gov/orphan/progovw.htm.

Contains Nonbinding Recommendations
Draft — Not for Implementation
9
Evaluation and Research (CBER).  CDER and CBER encourage early interaction with potential
352
sponsors so these types of questions can be discussed.  Such interactions could begin as early as
353
the pre-IND phase of drug development.
354
355


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Page 53898]
[FR Doc No: 2020-19201]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  Notice is hereby given, pursuant to the provisions of
the Government in the Sunshine Act, Public Law 94-409, the Securities
and Exchange Commission will hold an Open Meeting on Wednesday,
September 2, 2020 at 9:00 a.m.

PLACE:  The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS:  This meeting will begin at 9:00 a.m. (ET) and will be open to
the public via audio webcast only on the Commission's website at
www.sec.gov.

MATTERS TO BE CONSIDERED:  The Commission will consider whether to
adopt amendments to the Commission's rules implementing its
whistleblower program that would enhance claim processing efficiency,
and clarify and bring greater transparency to the framework used by the
Commission in exercising its discretion in determining award amounts,
as well as otherwise address specific issues that have developed during
the whistleblower program's history. The amendments reflect the
Commission's experience administering the program over the past decade.
The Commission will also consider whether to adopt interpretive
guidance concerning the term ``independent analysis'' in the
Commission's rules implementing its whistleblower program.

CONTACT PERSON FOR MORE INFORMATION:  For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact Vanessa A. Countryman, Office of the Secretary, at (202)
551-5400.

    Dated: August 26, 2020.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2020-19201 Filed 8-27-20; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Notices]
[Pages 25675-25676]
[FR Doc No: 2018-11828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1540]

Considerations for the Inclusion of Adolescent Patients in Adult
Oncology Clinical Trials; 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
``Considerations for the Inclusion of Adolescent Patients in Adult
Oncology Clinical Trials.'' The purpose of this draft guidance is to
provide the pharmaceutical industry, clinical investigators, and
institutional review boards with information to facilitate the
inclusion of adolescent patients (for purposes of this draft guidance
defined as ages 12 to 17) in relevant adult oncology clinical trials.
The draft guidance focuses on appropriate criteria for inclusion in
adult trials at various stages of drug development, considerations for
dosing and pharmacokinetic evaluations, safety monitoring, and ethical
requirements.

DATES: Submit either electronic or written comments on the draft
guidance by August 3, 2018 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-2018-D-1540 for ``Considerations for the Inclusion of Adolescent
Patients in Adult Oncology Clinical Trials.'' 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.gpo.gov/fdsys/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, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or Office
of Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith K. Chuk, Center for Drug
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale
Rd., Beltsville, MD 20705-1266,<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 ``Considerations for the Inclusion of Adolescent Patients in
Adult Oncology Clinical Trials.'' The purpose of this draft guidance is
to provide the pharmaceutical industry, clinical investigators, and
institutional review boards with information to facilitate the
inclusion of adolescent patients (for purposes of this draft guidance
defined as ages 12 to 17) in relevant adult oncology clinical trials.
The following topics are the focus of this guidance: (1) Appropriate
criteria for inclusion in adult trials at various stages of drug
development; (2) considerations for dosing and pharmacokinetic
evaluations; (3) safety monitoring; and (4) ethical requirements.

    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
``Considerations for the Inclusion of Adolescent Patients in Adult
Oncology Clinical Trials.'' 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. This draft guidance is not subject to
Executive Order 12866.

II. Electronic Access

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

    Dated: May 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11828 Filed 6-1-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63265-63267]
[FR Doc No: 2013-24769]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70705; File No. SR-CBOE-2013-097]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change Relating to The Customized Option Pricing Service

October 17, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on October 4, 2013, Chicago Board Options Exchange, Incorporated
(the ``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission'') the proposed rule change as described
in Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Chicago Board Options Exchange, Incorporated (the ``Exchange'' or
``CBOE'') proposes to: (i) Make available historical Customized Option
Pricing Service (``COPS'') data and (ii) revise the description of
COPS. The text of the proposed rule change is available on the
Exchange's Web site (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the
Secretary, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to: (i) Make available,
through CBOE's affiliate Market Data Express, LLC (``MDX''), historical
COPS data and (ii) revise the description of COPS.\3\
---------------------------------------------------------------------------

    \3\ The Exchange submitted proposed rule changes in 2012 to
establish COPS and COPS fees. See Securities Exchange Act Release
No. 67813 (September 10, 2012), 77 FR 56903 (September 14, 2012) and
Securities Exchange Act Release No. 67928 (September 26, 2012), 77
FR 60161 (October 2, 2012). The service was originally named
``Customized Option Valuation Service'' but is now referred to as
the ``Customized Option Pricing Service''.
---------------------------------------------------------------------------

    Background
    COPS provides subscribers with an ``end-of-day'' file \4\ of
valuations for Flexible Exchange (``FLEX'') \5\ options and certain
over-the-counter (``OTC'') options (``COPS Data''). COPS Data is
available for internal use and internal distribution by subscribers
(``Subscribers''). MDX offers COPS Data for sale to all market
participants.
---------------------------------------------------------------------------

    \4\ An end of day file refers to data that is distributed prior
to the opening of the next trading day.
    \5\ FLEX options are exchange traded options that provide
investors with the ability to customize basic option features
including size, expiration date, exercise style, and certain
exercise prices.
---------------------------------------------------------------------------

    COPS Data consists of indicative \6\ values for three categories of
``customized'' options. The first category of options is all open
series of FLEX options listed on any exchange that offers FLEX options
for trading.\7\ The second category is OTC options that have the same
degree of customization as FLEX options. The third category includes
options with strike prices expressed in percentage terms. Values for
such options are expressed in percentage terms and are theoretical
values.\8\
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    \6\ ``Indicative'' values are indications of potential market
prices only and as such are neither firm nor the basis for a
transaction.
    \7\ Current FLEX options open interest spans over 2,000 series
on over 300 different underlying securities.
    \8\ These values are theoretical in that they are indications of
potential market prices for options that have not traded (i.e. do
not yet exist). Market participants sometimes express option values
in percentage terms rather than in dollar terms because they find it
is easier to assess the change, or lack of change, in the
marketplace from one day to the next when values are expressed in
percentage terms.
---------------------------------------------------------------------------

    The fees that MDX charges for COPS Data are set forth on the Price
List on the MDX Web site (www.marketdataexpress.com). MDX currently
charges a fee per option per day for COPS Data. The amount of the fee
is reduced based on the number of options purchased. A subscriber pays
$1.25 per option per day for each option purchased up to 50 options,
$1.00 per option per day for each option purchased from 51 to 100
options, $0.75 per option per day for each option purchased from 101 to
500 options, and $0.50 per option per day for each option purchased
over 500 options.
    Historical COPS Data
    The Exchange proposes to make available, through MDX, historical
COPS data (``Historical COPS Data''). Historical COPS Data consists of
COPS Data that is over one month old (i.e., copies of the ``end-of-
day'' COPS file that are over one month old). Market participants would
also be able to purchase Historical COPS Data through the MDX Web site.
All market participants would be charged the same fees for Historical
COPS Data. The Exchange will file a separate proposed rule change to
establish the fees to be charged by MDX for Historical COPS Data.
    COPS Description
    COPS Data is currently available only for internal use and internal
distribution by Subscribers. Pursuant to a written subscriber agreement
between MDX and a Subscriber, a Subscriber may not act as a vendor and
distribute the Data externally. The Exchange proposes to make COPS Data
and Historical COPS Data (collectively, the ``Data'') available to
Subscribers for internal use and internal distribution only. The
Exchange also proposes to make COPS Data and Historical COPS Data
available to ``Customers'' who, pursuant to a written vendor agreement
between MDX and a Customer, may distribute the Data externally (i.e.,
act as a vendor) and/or use and distribute the Data internally.
Customers would be subject to the same fees that Subscribers pay for
internal use and internal distribution of the Data. Customers would not
be charged any fees initially for their external distribution of the
Data. The Exchange would file a proposed rule change to establish the
fees to be charged to Customers by MDX for external distribution of the
Data.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Securities Exchange Act of 1934 (the ``Act'') and the rules and
regulations thereunder applicable to the Exchange and, in particular,
the requirements of Section 6(b) of the Act.\9\ Specifically, the
Exchange believes the proposed rule change is consistent with the
Section

6(b)(5) \10\ requirements that the rules of an exchange be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in securities, to remove impediments to and perfect the mechanism of a
free and open market and a national market system, and, in general, to
protect investors and the public interest. Additionally, the Exchange
believes the proposed rule change is consistent with the Section
6(b)(5)\11\ requirement that the rules of an exchange not be designed
to permit unfair discrimination between customers, issuers, brokers, or
dealers because the Data would be available to all of MDX's Customers
and Subscribers on an equivalent basis.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
    \11\ Id.
---------------------------------------------------------------------------

    In adopting Regulation NMS, the Commission granted self-regulatory
organizations and broker-dealers increased authority and flexibility to
offer new and unique market data to the public. It was believed that
this authority would expand the amount of data available to consumers,
and also spur innovation and competition for the provision of market
data. The Exchange believes that this proposal is in keeping with those
principles by promoting increased transparency through the
dissemination of useful data and also by clarifying its availability to
market participants. The Exchange believes the proposal to allow
Customers of the Data to distribute the Data externally would help
further the dissemination of the Data.
    Additionally, the Exchange is making a voluntary decision to make
this data available. The Exchange is not required by the Act in the
first instance to make the Data available. Further, Historical COPS
Data consists of COPS Data that is over one month old, so no new data
would be made available by the introduction of the Historical COPS Data
product.

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act. To the contrary, the Exchange
believes the proposed rule change is pro-competitive in that it would
allow the Exchange, through MDX, to disseminate COPS data on a
voluntary basis. COPS is voluntary on the part of the Exchange, which
is not required to offer such services, and voluntary on the part of
prospective subscribers that are not required to use it. The Exchange
notes there are at least a small number of market data vendors that
produce option value data that is similar to COPS data and market data
users may elect to buy these other products if they choose.\12\ The
Options Clearing Corporation (``OCC'') also produces FLEX option value
data that is similar to the FLEX option value data that is included in
COPS.\13\ The Exchange believes that COPS helps attract new users and
new order flow to the Exchange, thereby improving the Exchange's
ability to compete in the market for options order flow and executions.
---------------------------------------------------------------------------

    \12\ These vendors include SuperDerivatives, Markit, Prism, and
Bloomberg's BVAL service.
    \13\ The OCC makes this data available on its Web site at http://www.theocc.com/webapps/flex-reports.
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received from Members, Participants, or Others

    The Exchange neither solicited nor received comments on the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not:
    A. Significantly affect the protection of investors or the public
interest;
    B. Impose any significant burden on competition; and
    C. Become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, it has
become effective pursuant to Section 19(b)(3)(A) of the Act \14\ and
Rule 19b-4(f)(6) \15\ thereunder. At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission will institute proceedings to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A).
    \15\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2013-097 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2013-097. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for Web site viewing and printing in
the Commission's Public Reference Room, 100 F Street NE., Washington,
DC 20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2013-097 and should be
submitted on or before November 13, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-24769 Filed 10-22-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Proposed Rules]
[Pages 29229-29232]
[FR Doc No: 2021-11315]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2021-0088; FRL-10023-95]

Receipt of Pesticide Petitions Filed for Residues of Pesticide
Chemicals in or on Various Commodities May 2021

AGENCY: Environmental Protection Agency (EPA).

ACTION: Filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of initial
filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before July 1, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition (PP) of interest as shown in the
body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration
Division (7505P), main telephone number:<PHONE_NUMBER>, email address:
<EMAIL_ADDRESS>or Charles Smith, Biopesticides and Pollution
Prevention Division (7511P), main telephone number:<PHONE_NUMBER>,
email address<EMAIL_ADDRESS>The mailing address for each
contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each pesticide petition summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing receipt of pesticide petitions filed under
section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain data or information prescribed in FFDCA section 408(d)(2), 21
U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency
of the submitted data at this time or whether the data supports
granting of the pesticide petitions. After considering the public
comments, EPA intends to evaluate whether and what action may be
warranted. Additional data may be needed before EPA can make a final
determination on these pesticide petitions.
    Pursuant to 40 CFR 180.7(f), summaries of the petitions that are
the subject of this document, prepared by the petitioners, are included
in dockets EPA has created for these rulemakings. The dockets for these
petitions are available at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA
is publishing notice of the petitions so that the public has an
opportunity to comment on these requests for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petitions may be obtained
through the petition summaries referenced in this unit.

A. Amended Tolerance Exemptions for Inerts (Except PIPS)

    PP IN-11493. (EPA-HQ-OPP-2021-0274). ADAMA Makhteshim, Ltd. c/o
Makhteshim Agan of North America d/b/a ADAMA, 3120 Highwoods Blvd.,
Suite 100, Raleigh, NC 27604, requests to amend an exemption from the
requirement of a tolerance in 40 CFR 180.920 for residues of
acetophenone (CAS Reg. No. 98-86-2) when used as an inert ingredient in
pesticide formulations applied to growing crops. The petitioner
believes no analytical method is needed because it is not required for
an exemption from the requirement of a tolerance. Contact: RD.

B. Amended Tolerances for Inerts

    PP IN-11407. (EPA-HQ-OPP-2021-0185). Management Contract Services,
Inc. on behalf of Landis International, Inc., P.O. Box 5126, Valdosta,
GA 31603, requests to amend the tolerance in 40 CFR 180.460 for
residues of Benoxacor (2,2-dichloro-1-(3-methyl-2,3-dihydro-1,4-
benzoxazin-4-yl) ethenone) (CAS Reg. No. 98730-04-2) when used as a
pesticide inert ingredient (safener) in pesticide formulations to
include any herbicide in or on raw agricultural commodities for which
tolerances have been established for those active ingredients at 0.01
parts per million (ppm). Adequate enforcement methodology, GC/NPD, is
available to enforce the tolerance expression. The analytical
methodology for the determination of benoxacor and its metabolites in
plant and animal commodities is Ciba Analytical Method AG536(C).
Contact: RD.

C. New Tolerance Exemptions for Inerts (Except PIPS)

    1. PP IN-11401. (EPA-HQ-OPP-2021-0308). The Innovative Reform Group
on behalf of The Clorox Company, P.O. Box 493, Pleasanton, CA 94566-
0803, requests to establish an exemption from the requirement of a
tolerance under 40 CFR part 180.940(a) for residues of various
fragrance components (CAS Reg No. multiple) when used as inert
ingredients in antimicrobial pesticide formulations for use on food
contract surfaces in public eating places, dairy processing equipment,
and food processing equipment and utensils at end-use concentrations
not to exceed 33 ppm. Contact: RD.
    2. PP IN-11402. (EPA-HQ-OPP-2021-0311). The Innovative Reform Group
on behalf of The Clorox Company, P.O. Box 493, Pleasanton, CA 94566-
0803, requests to establish an exemption from the requirement of a
tolerance under 40 CFR part 180.940(a) for residues of various
fragrance components (CAS Reg No. multiple) when used as inert
ingredients in antimicrobial pesticide formulations for use on food
contract surfaces in public eating places, dairy processing equipment,
and food processing equipment and utensils at end-use concentrations
not to exceed 5 ppm. Contact: RD.
    3. PP IN-11409. (EPA-HQ-OPP-2021-0321). Evonik Corporation, 299
Jefferson Road, Parsippany, NJ 07054, requests to establish an
exemption from the requirement of a tolerance for residues of Silane,
hexadecyltrimethoxy-, hydrolysis products with silica (CAS Reg. No.
199876-45-4) when used as a pesticide inert ingredient (stabilizer) in
pesticide formulations under 40 CFR part 180.910 and 180.950. The
petitioner believes no analytical method is needed because it is not
required for an exemption from the requirement of a tolerance. Contact:
RD.
    4. IN-11410. (EPA-HQ-OPP-2021-0292). Spring Regulatory Sciences
(6620 Cypresswood Dr., Suite 250 Spring, TX 77379) on behalf of Earth
Science Laboratories, Inc., (113 SE 22nd Street, Suite 1, Bentonville,
AR 72712) requests to establish an exemption from the requirement of a
tolerance for residues of polyammonium bisulfate (CAS Reg. No. 10043-
02-4) to include the use as an inert ingredient (carrier, adjuvant,
buffer and stabilizer) applied to growing crops pre- and post-harvest
under 40 CFR part 180.910 and in antimicrobial formulations applied to
food-contact surfaces in public eating places, dairy-processing
equipment, and food-processing equipment and utensils under 40 CFR part
180.940(a). The petitioner believes no analytical method is needed
because it is not required for an exemption from the requirement of a
tolerance. Contact: RD.
    5. PP IN-11458. (EPA-HQ-OPP-2021-0273). Ingredion Incorporated, 5
Westbrook Corporate Center, Westchester, IL 60154, requests to
establish an exemption from the requirement of a tolerance for residue
of starch, 1-octenylbutanedioate, aluminum salt (CAS Reg. No. 9087-61-
0) when used as an inert ingredient in pesticide formulations applied
to growing crops under 40 CFR 180.920. The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. Contact: RD.
    6. PP IN-11514. (EPA-HQ-OPP-2021-0320). Spring Regulatory Sciences,
6620 Cypresswood Dr, Suite 250, Spring, TX 77379 on behalf of Nouryon
Chemicals LLC, requests to establish an exemption from the requirement
of a tolerance in 40 CFR part 180.960 for residues of Glycerides, soya
mono- and di-ethoxylated (CAS Reg. No. 68553-06-0) when used as a
pesticide inert ingredient in pesticide formulations Joint Inerts Task
Force Cluster Support. The petitioner believes no analytical method is
needed because it is not required for an exemption from the requirement
of a tolerance. Contact: RD.
    7. PP IN-11515. (EPA-HQ-OPP-2021-0323). Spring Regulatory Sciences,
6620 Cypresswood Dr., Suite 250, Spring, TX 77379 on behalf of Nouryon
Chemicals LLC, requests to establish an exemption from the requirement
of a tolerance in 40 CFR part 180.910 and 180.930 for residues of
Oxirane, 2-methyl-, polymer with oxirane, mono-C9-11-isoalkyl ethers,
C10-rich, phosphates, potassium salts (CAS Reg. No. 2275654-37-8) when
used as a pesticide inert ingredient in pesticide formulations Joint
Inerts Task Force Cluster Support. The petitioner believes no
analytical method is needed because it is not required for an exemption
from the requirement of a tolerance. Contact: RD.

D. New Tolerance Exemptions for Non-Inerts (Except PIPS)

    PP 0F8851. (EPA-HQ-OPP-2021-0232). Biofungitek, S.L., Parque
Cient[iacute]fico y Tecnol[oacute]gico de Bizkaia, Astondo Bidea
(Building 612), 48160 Derio, Spain (c/o Compliance Services
International, 7501 Bridgeport Way West, Lakewood, WA 94899), requests
to establish an exemption from the requirement of a tolerance in 40 CFR
part 180 for residues of the biochemical fungicide potassium carbonate
in or on all agricultural food commodities. The petitioner believes no
analytical method is needed because the requirement is not applicable
as an exemption from tolerance has been submitted. Potassium carbonate,
a salt occurring abundantly in nature, would dissociate into its
component ions (potassium and carbonate) once dissolved in water for
application. In turn, carbonate will be part of an equilibrium mixture
of bicarbonate, carbonate, and carbonic acid.Being naturally abundant,
these ions would add to the like ions that already exist in the
environment. Potassium and carbonate ions would be indistinguishable
from the natural background of inorganic ions. Contact: BPPD.

E. New Tolerances for Non-Inerts

    1. PP 0E8888. (EPA-HQ-OPP-2021-0204). Interregional Research
Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08450, requests to establish a tolerance in 40 CFR
180.690 for residues of the fungicide, mandestrobin, 2-[(2,5-
dimethylphenoxy)methyl]-[alpha]-methoxy-N-methylbenzeneacetamide in or
on lettuce, head at 0.08 ppm, and lettuce, leaf at 4 ppm. The
``Determination of S2200 and De-Xy-S-2200 in Crops,'' Method RM-48C-2B,
which uses LC-MS/MS, is used to measure and evaluate the chemical.
Contact: RD.
    2. PP 0E8881. (EPA-HQ-2021-0156). IR-4, Project Headquarters,
Rutgers, The State University of New Jersey, 500 College Road East,
Suite 201 W, Princeton, NJ 08450, requests to establish a tolerance in
40 CFR 180.337 for residues of the fungicide/bactericide,
oxytetracycline, (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-
1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-
1,11-dioxo-2-naphthacenecarboxamide, in or on the commodities olive at
0.1 ppm, walnut, black at 0.1 ppm and walnut, English at 0.1 ppm. A
high-performance liquid chromatography method with tandem mass
spectrometry detection (LC/MS/MS) is used to measure and evaluate the
chemical. Contact: RD.
    3. PP 1E8911. (EPA-HQ-OPP-2021-0213). IR-4, Rutgers, The State
University of New Jersey, 500 College Road East, Suite 201 W,
Princeton, NJ 08540, requests to establish a tolerance in 40 CFR part
180.434 for residues of the fungicide, propiconazole, (1-[[2-(2,4-
dichlorophenyl)-4-propyl-1,3-dioxolan-

2-yl]methyl]-1H-1,2,4-triazole) and its metabolites determined by
measuring only those propiconazole residues convertible to 2,4-
dichlorobenzoic acid (2,4-DCBA) in or on the raw agricultural commodity
vegetable, brassica, head and stem, group 5-16 at 4 ppm. Analytical
methods AG-626 and AG-454A were developed for the determination of
residues of propiconazole and its metabolites containing the DCBA
moiety and are used to measure and evaluate the chemical. Contact: RD.
    4. PP 0F8838. (EPA-HQ-OPP-2020-0728). Valent U.S.A. LLC, 1600
Riviera Avenue, Suite 200, Walnut Creek, CA 94596 requests to establish
a tolerance in 40 CFR part 180 for residues of the fungicide
fluopicolide in or on the following commodities: Cereal grains (crop
group 15), aspirated grain fractions at 0.07 ppm; cereal grains (crop
group 15), grain at 0.02 ppm; cereal grains (crop group 15), milled
byproducts at 0.07 ppm; cotton gin byproducts at 0.20 ppm; foliage of
legume vegetables (crop group 7), forage at 0.15 ppm; foliage of legume
vegetables (crop group 7), hay, straw, and vines at 0.20 ppm; forage,
fodder and straw of cereal grains (crop group 16) at 0.50 ppm; grass
forage, fodder, and hay (crop group 17) at 0.50 ppm; legume vegetables
(crop group 6), seed, pea, bean (succulent or dried, except listed
beans) at 0.03 ppm; nongrass animal feeds (crop group 18), forage,
fodder, straw and hay at 0.50 ppm; oilseeds (crop group 20), refined
oil at 0.10 ppm; oilseeds (crop group 20), seed at 0.04 ppm; peanut hay
at 0.60 ppm; peanut nutmeat at 0.04 ppm; peanut, refined oil at 0.10
ppm; soybean refined oil at 0.08 ppm. Practical analytical methods for
detecting and measuring levels of fluopicolide and its metabolites have
been developed and validated in/on all appropriate plant and animal
matrices. Contact: RD.
    5. PP 9F8777. (EPA-HQ-OPP-2019-0542). Syngenta Crop Protection,
LLC, P.O. Box 18300, Greensboro, NC 27419, requests to establish a
tolerance in 40 CFR part 180 for residues of the herbicide,
bicyclopyrone, in or on lemongrass, dried at 0.5 ppm; lemongrass, fresh
at 0.3 ppm; rosemary, dried at 0.3 ppm; rosemary, fresh at 0.03 ppm;
wormwood, dried at 0.09 ppm and wormwood, fresh at 0.05 ppm. The
Analytical methods GRM030.05A, GRM030.05B, GRM030.08A is used to
measure and evaluate the chemical Bicyclopyrone. Contact: RD.

    Authority: 21 U.S.C. 346a.

    Dated: May 12, 2021.
Delores Barber,
Director, Information Technology and Resources Management Division,
Office of Program Support.
[FR Doc. 2021-11315 Filed 5-28-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Pages 22095-22096]
[FR Doc No: 2011-9581]

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

[Docket ID Number EPA-HQ-OECA-2010-0710; FRL-9298-2]

Clean Air Act: Opportunity To Comment, Activities Required by
Federal Facilities Compliance Agreement With the Tennessee Valley
Authority

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has entered into a
federal facilities compliance agreement with the Tennessee Valley
Authority (TVA), Docket No. CAA-04-2010-1760 (Compliance Agreement) to
resolve alleged violations of the Clean Air Act and its implementing
regulations at the eleven facilities that TVA owns and operates in
Alabama, Kentucky, and Tennessee. EPA is hereby providing public notice
of this Compliance Agreement and providing an opportunity for
interested persons to comment on the Compliance Agreement.

DATES: Comments are due on or before May 20, 2011.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OECA-2010-0710, by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket ID No. EPA-
HQ-OECA-2010-0710.
     Mail: Enforcement and Compliance Docket Information
Center, Environmental Protection Agency, Mailcode: 2822T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No.
EPA-HQ-OECA-2010-0710.
     Hand Delivery: Enforcement and Compliance Docket
Information Center in the EPA Docket Center (EPA/DC), EPA West, Room
3334, 1301 Constitution Avenue, NW., Washington, DC. The EPA Docket
Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket is (202)
566-1927.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OECA-
2010-0710. EPA's policy is that all comments received 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 information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov
or<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-OECA-2010-0710.
The http://www.regulations.gov Web site is an ``anonymous access''
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an e-mail comment directly to EPA without going through http://www.regulations.gov your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet. If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit. 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. Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses. For additional information about EPA's public docket visit the
EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Enforcement and
Compliance Docket Information Center in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jason Dressler, South Air Enforcement
Section (9T25), Environmental Protection Agency, 61 Forsyth Street,
SW., Atlanta, Georgia 30303; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
Summary of the Proposed Action for Comment

    EPA alleges in the Compliance Agreement and the companion Consent
Agreement and Final Order (CAFO), Docket No. CAA-04-2010-1528(b), that
TVA failed to comply with certain requirements of the Clean Air Act
intended to protect air quality. TVA is also concurrently entering into
a federal consent decree (Consent Decree) with the State of Alabama,
the Commonwealth of Kentucky, the State of North Carolina, the State of
Tennessee and three non-governmental organizations, the National Parks
Conservation Association, the Sierra Club, and Our Children's Earth
Foundation, pertaining to such alleged violations of the Clean Air Act.
Pursuant to the proposed Consent Decree, TVA will perform substantially
the same relief as required by the Compliance Agreement. Neither the
CAFO nor the Consent Decree are subject to this notice for public
comment. EPA is only requesting public comment regarding the Compliance
Agreement, Docket No. CAA-04-2010-1760.
    EPA alleges that TVA violated the Prevention of Significant
Deterioration, Nonattainment New Source Review, New Source Performance
Standards, and Title V provisions of the Clean Air

Act, 42 U.S.C. 7470-7492, 7501-7515, 7411, 7661-7661f, and related
state and federal implementing regulations at the following coal-fired
power plants: The Allen Fossil Plant located in Shelby County, Memphis,
Tennessee; the Bull Run Fossil Plant, located in Anderson County,
Clinton, Tennessee; the Colbert Fossil Plant, located in Colbert
County, Tuscumbia, Alabama; the Cumberland Fossil Plant, located in
Stewart County, Cumberland City, Tennessee; the John Sevier Fossil
Plant, located in Hawkins County, Rogersville, Tennessee; the Kingston
Fossil Plant, located in Roane County, Kingston, Tennessee; the
Paradise Fossil Plant, located in Muhlenburg County, Drakesboro,
Kentucky; and the Shawnee Fossil Plant, located in McCracken County,
Paducah, Kentucky.
    The alleged violations arise from the construction of modifications
at units at these plants and operation of such units in violation of
the requirements of the Act. EPA alleges that TVA failed to obtain
appropriate permits prior to making major modifications and failed to
install and apply required pollution control devices to reduce
emissions of various air pollutants from units at the plants identified
above. The CAFO assesses a civil penalty of $8 million to resolve these
alleged violations. In addition to the $8 million proposed civil
penalty TVA will pay to EPA, pursuant to the Consent Decree TVA will
pay $500,000 to Alabama, $500,000 to Kentucky, and $1 million to
Tennessee to resolve alleged violations of the Clean Air Act and
related state and federal implementing regulations.
    The Compliance Agreement addresses units at the eight plants
identified above as well units at the following three plants that were
not alleged to be in violation of the Clean Air Act or related state
and federal implementing regulations: the Gallatin Fossil Plant located
in Sumner County, Gallatin, Tennessee; the Johnsonville Fossil Plant
located in Humphreys County, near Waverly, Tennessee; and the Widows
Creek Fossil Plant located in Jackson County, near Stevenson, Alabama.
The Compliance Agreement requires installation, upgrading, and
continuous operation of pollution control devices on a number of the 59
units at the 11 plants addressed in this Compliance Agreement. The
Compliance Agreement also requires TVA to permanently shut down and
cease to operate two units at the John Sevier plant, six units at the
Widows Creek plant, and all ten units at the Johnsonville plant.
Further, the Compliance Agreement imposes emissions caps that limit the
total amount of nitrogen oxides and sulfur dioxide that can be
collectively emitted by all 59 units at these plants. And, the
Compliance Agreement imposes obligations that will reduce emissions of
particulate matter.
    The Compliance Agreement requires TVA to spend $290 million for
environmental mitigation projects in its service territory to mitigate
the alleged adverse effects of its past alleged violations. Pursuant to
the Consent Decree, TVA will fund an additional $60 million in
environmental mitigation projects in Alabama, Kentucky, North Carolina,
and Tennessee.

    Dated: April 15, 2011.
Adam M. Kushner,
Director, Office of Civil Enforcement.
[FR Doc. 2011-9581 Filed 4-19-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Pages 73064-73065]
[FR Doc No: 2014-28764]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-515-000]

Great Bay Energy VII, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding,
of Great Bay Energy VII, LLC's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is December 22, 2014.
    The Commission encourages electronic submission of protests and

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

    Dated: December 2, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-28764 Filed 12-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: February 13, 2007 (Volume 72, Number 29)]
[Notices]
[Page 6722]
[DOCID:fr13fe07-35]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12596-001]

Ophir Valley Land Company, LLC; Notice of Surrender of
Preliminary Permit

February 6, 2007.
    Take notice that Ophir Valley Land Company, LLC, permittee for the
proposed Carbonero Hydroelectric Project, has requested that its
preliminary permit be terminated. The permit was issued on January 4,
2006, and would have expired on December 31, 2008.\1\ The project would
have been located on the Carbonero Mine Adit near Ophir, in San Miguel
County, Colorado.
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    \1\ 114 FERC ] 62,005.
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    The permittee filed the request on January 30, 2007, and the
preliminary permit for Project No. 12596 shall remain in effect through
the thirtieth day after issuance of this notice unless that day is a
Saturday, Sunday, part-day holiday that affects the Commission, or
legal holiday as described in section 18 CFR 385.2007, in which case
the effective date is the first business day following that day. New
applications involving this project site, to the extent provided for
under 18 CFR Part 4, may be filed on the next business day.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-2384 Filed 2-12-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 119 (Wednesday, June 20, 2018)]
[Notices]
[Page 28637]
[FR Doc No: 2018-13198]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP18-893-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Amendment to Negotiated Rate
Agreement-Macquarie Energy LLC to be effective 6/12/2018.
    Filed Date: 6/12/18.
    Accession Number: 20180612-5087.
    Comments Due: 5 p.m. ET 6/25/18.

    Docket Numbers: RP18-894-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Sec.  4(d) Rate Filing: Chesapeake/Territory
Negotiated Rate to be effective 6/1/2018.
    Filed Date: 6/13/18.
    Accession Number: 20180613-5027.
    Comments Due: 5 p.m. ET 6/25/18.

    Docket Numbers: RP18-895-000.
    Applicants: Paiute Pipeline Company.
    Description: Sec.  4(d) Rate Filing: Nonconforming TSA Nos. F30,
F36, and F49 to be effective 5/23/2018.
    Filed Date: 6/13/18.
    Accession Number: 20180613-5063.
    Comments Due: 5 p.m. ET 6/25/18.

    Docket Numbers: RP18-896-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate ConEd to
Colonial 796693 to be effective 6/14/2018.
    Filed Date: 6/13/18.
    Accession Number: 20180613-5086.
    Comments Due: 5 p.m. ET 6/25/18.

    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: June 14, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-13198 Filed 6-19-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Page 35789]
[FR Doc No: 2016-13176]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4250-DR; Docket ID FEMA-2016-0001]

Missouri; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Missouri (FEMA-4250-DR), dated January 21, 2016, and
related determinations.

DATES: Effective May 13, 2016.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, William L.
Vogel, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Michael L. Parker as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2016-13176 Filed 6-2-16; 8:45 am]
 BILLING CODE 9111-23-P