[Federal Register Volume 88, Number 214 (Tuesday, November 7, 2023)]
[Notices]
[Pages 76752-76754]
[FR Doc No: 2023-24590]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Numbers: PR24-5-000.
    Applicants: UGI Utilities, Inc.
    Description: 284.123(g) Rate Filing: Rate Election 11-1-2023 to be
effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5161.
    Comment Date: 5 p.m. ET 11/21/23.
    Protest Date: 5 p.m. ET 1/2/24.

    Docket Numbers: RP24-101-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: 4(d) Rate Filing: Negotiated Rate Agreement Update
(SoCal Nov 23) to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5158.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-102-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: 4(d) Rate Filing: TETLP ASA DEC 2023 Filing to be
effective 12/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5171.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-103-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: 4(d) Rate Filing: Negotiated Rate Agreements--Various
Shippers 2023 to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5188.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-104-000.
    Applicants: Dauphin Island Gathering Partners.
    Description: 4(d) Rate Filing: Negotiated Rate Filing--11.01.23
Chevron MDQ to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5203.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-105-000.
    Applicants: Rockies Express Pipeline LLC.
    Description: 4(d) Rate Filing: REX 2023-10-31 Negotiated Rate
Agreements to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5207.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-106-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: 4(d) Rate Filing: Negotiated Rates--Union Gas contract
860007 to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5211.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-107-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: 4(d) Rate Filing: Negotiated Rates--Bug Co Nat 911814
Releases 11-01-23 to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5212.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-108-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: 4(d) Rate Filing: Destin Pipeline Negotiated Rate
Agreement Filing to be effective 11/1/2023.
    Filed Date: 10/31/23.

    Accession Number: 20231031-5231.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-109-000.
    Applicants: Ruby Pipeline, L.L.C.
    Description: 4(d) Rate Filing: RP 2023-10-31 FL&U and EPC Rate
Adjustment to be effective 12/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5233.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-110-000.
    Applicants: Sierrita Gas Pipeline LLC.
    Description: 4(d) Rate Filing: 2023 Oct Quarterly FL&U Filing to be
effective 12/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5237.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-111-000.
    Applicants: LA Storage, LLC.
    Description: 4(d) Rate Filing: Filing of Negotiated Rate,
Conforming IW Agreements to be effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5238.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-112-000.
    Applicants: Northern Natural Gas Company.
    Description: 4(d) Rate Filing: 20231031 Negotiated Rate to be
effective 11/1/2023.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5264.
    Comment Date: 5 p.m. ET 11/13/23.
    Docket Numbers: RP24-113-000.
    Applicants: Texas Eastern Transmission, LP.
    Description: 4(d) Rate Filing: Negotiated Rates--Keyspan 8985743
Releases to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5014.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-114-000.
    Applicants: Enable Mississippi River Transmission, LLC.
    Description: Compliance filing: 2023 Annual Report of Penalty
Revenue Credits to be effective N/A.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5035.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-115-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Compliance filing: 2023 Annual Report of Total Penalty
Revenue Credits to be effective N/A.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5036.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-116-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Compliance filing: 2023 Annual Report of Linked Firm
Service Penalty Revenue Credits to be effective N/A.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5039.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-117-000.
    Applicants: Gulf Run Transmission, LLC.
    Description: Compliance filing: 2023 Annual Report of Penalty
Revenue Credits to be effective N/A.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5042.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-118-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: 4(d) Rate Filing: Negotiated Rates--November 2023
Clean Up Filing to be effective 12/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5052.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-119-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: 4(d) Rate Filing: Negotiated Rates--Various Releases
eff 11-1-23 to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5054.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-120-000.
    Applicants: Carlsbad Gateway, LLC.
    Description: 2023 Penalty Revenue Crediting Report of Carlsbad
Gateway, LLC.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5071.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-121-000.
    Applicants: Columbia Gas Transmission, LLC.
    Description: 4(d) Rate Filing: OTRA Winter 2023 to be effective 12/
1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5081.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-122-000.
    Applicants: NEXUS Gas Transmission, LLC.
    Description: 4(d) Rate Filing: Negotiated Rates--Various Releases
to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5087.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-123-000.
    Applicants: Alliance Pipeline L.P.
    Description: 4(d) Rate Filing: Negotiated Rates--Various Nov 1 2023
Contract Adjustments to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5090.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-124-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: 4(d) Rate Filing: Negotiated Rates--Northern to NRG
Business 3018 to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5092.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-125-000.
    Applicants: Alliance Pipeline L.P.
    Description: 4(d) Rate Filing: Negotiated Rates--Various Nov 1 2023
Releases to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5093.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-126-000.
    Applicants: Equitrans, L.P.
    Description: 4(d) Rate Filing: Negotiated Rate Capacity Release
Agreement--11/1/2023 to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5100.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-127-000.
    Applicants: Texas Gas Transmission, LLC.
    Description: 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Kaiser Ohio
35448 to Kaiser Appalachian 57364) to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5123.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-128-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: 4(d) Rate Filing: Cap Rel Neg Rate Agmt (Methanex
42805 to Tenaska 57451) to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5131.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP24-129-000.
    Applicants: Gulf South Pipeline Company, LLC.
    Description: 4(d) Rate Filing: Cap Rel Neg Rate Agmts (Osaka 46429
to ConocoPhillips 57488, Texla 57490) to be effective 11/1/2023.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5132.
    Comment Date: 5 p.m. ET 11/13/23.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) 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.

Filings in Existing Proceedings

    Docket Numbers: RP19-351-007.

    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Compliance filing: Cost-Revenue Study Docket No. RP19-
351__to be effective N/A.
    Filed Date: 11/1/23.
    Accession Number: 20231101-5073.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP23-1038-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Report Filing: In-Service Notice_REA Interim_a_Docket
No. CP21-94 to be effective N/A.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5157.
    Comment Date: 5 p.m. ET 11/13/23.

    Docket Numbers: RP23-1055-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Report Filing: In-Service Notice_REA Interim_b_Docket
No. CP21-94 to be effective N/A.
    Filed Date: 10/31/23.
    Accession Number: 20231031-5164.
    Comment Date: 5 p.m. ET 11/13/23.
    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    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>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: November 1, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-24590 Filed 11-6-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76538-76539]
[FR Doc No: 2022-27072]

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

DEPARTMENT OF TRANSPORTATION

[DOCKET: DOT-OST-2013-0074]

Agency Information Collection; Activity Under OMB Review: Foreign
Air Carrier Application for Statement of Authorization, ICR-2106-0035

AGENCY: Office of the Secretary (OST), Department of Transportation
(DOT).

ACTION: Notice and request for comments; Request OMB Clearance for
extension of a currently approved information collection, Foreign Air
Carrier Application for Statement of Authorization.

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

SUMMARY: In compliance with the Paperwork Reduction Act, this notice
announces that the Information Collection Request, abstracted below, is
being forwarded to the Office of Management and Budget for extension of
approval of currently approved ICR-2106-0036, Foreign Air Carrier
Application for Statement of Authorization. Earlier, a Federal Register
Notice with a 60-day comment period was published on August 12, 2022.
The agency received one comment from Bakersfield College--Britain
Cambridge State University stating, ``Thank you''.

DATES: Written comments should be submitted by January 8, 2023.

ADDRESSES: Comments should be sent to OMB at the address that appears
below and should identify the associated OMB Approval Number 2106-0035
and Docket DOT-OST-2013-0074.

FOR FURTHER INFORMATION CONTACT: Darren Jaffe,<PHONE_NUMBER>, Office
of International Aviation, U.S. Department of Transportation, 1200 New
Jersey Avenue SE, Room W86-441, Washington, DC 20590. Office hours are
from 9 a.m. to 5:30 p.m., Monday through Friday, except Federal
holidays.

SUPPLEMENTARY INFORMATION:
    OMB Approval No.: 2106-0035.
    Title: Foreign Air Carrier Application for Statement of
Authorization.
    Form No.: Form OST 4540.
    Type of Review: Extension of a currently approved collection.
    Respondents: Foreign Air Carriers.
    Number of Respondents: approximately 100.
    Estimated Time per Response: 2.25 hours per application.
    Total Annual Burden: 1,000 hours.
    Abstract: Applicants use Form OST 4540 to request statements of
authorization to conduct numerous types of operations authorized under
Title 14, CFR part 212. The form requires basic information regarding
the carrier(s) conducting the operation, the

party filing the form, the operations being conducted, the number of
third- and fourth-freedom flights conducted in the last twelve-month
period, and certification of reciprocity from the carrier's homeland
government. DOT analysts will use the information collected to
determine if applications for fifth-freedom operations meet the public
interest requirements necessary to authorize such applications.
    Burden Statement: We estimate that the industry-wide total hour
burden for this collection to be approximately 1,000 hours or
approximately 2.25 hours per application. Conservatively, we estimate
the compilation of background information will require 1.75 hours, and
the completion and submission of OST Form 4540 will require thirty (30)
minutes. Reporting the number of third- and fourth-freedom operations
conducted by an applicant carrier will require collection of flight
data, and detailed analysis to determine which flights conducted by the
carrier are third- and fourth-freedom. Applicants should be able to use
data collected for the Department's T-100 program to provide this
information (under this program, carriers are required periodically to
compile and report certain traffic data to the Department, as more
fully described in the Docket referenced in footnote 1 below). The
Bureau of Transportation Statistics (BTS) provide carriers with a
computer program that allows them to compile and monitor, among other
things, flight origin and destination data, to be used in making the
carriers' T-100 submissions.\1\
---------------------------------------------------------------------------

    \1\ The rule-making associated with the T-100 program can be
found on the Federal Docket Management System (FDMS) at https://www.regulations.gov, in Docket DOT-OST-1998-4043. Information
regarding burden hours is on file in the Office of Aviation Analysis
(X-50).
---------------------------------------------------------------------------

    We estimated that carriers will require 1.25 hours per application
\2\ to compile and analyze the data necessary to disclose the number of
third- and fourth-freedom flights conducted within the twelve-month
period preceding the filing of an application.
---------------------------------------------------------------------------

    \2\ The Office of Aviation Analysis (X-50) estimated that small-
carriers would require 1 burden hour per report, and large carriers
would require 3 burden hours per report to analyze and report T-100
program data. Considering that the data required in this information
collection can be derived from data already collected, we have taken
an average of the estimated time required, and conservatively
shortened the time by 45 minutes because no new data entry will be
required.
---------------------------------------------------------------------------

    Foreign carriers will also have to provide evidence that their
homeland government will afford reciprocity to U.S. carriers seeking
authority for the similar fifth-, sixth- and seventh- freedom
operations. Carriers may cite certifications submitted by carriers from
the same homeland if that homeland issued such certification within the
preceding six-month period. Approximately 100 carriers from roughly 30
distinct homelands use OST Form 4540 to apply for statements of
authorization annually. We estimate that one foreign carrier from any
given homeland will expend roughly 4 hours every six-months to obtain
certification from its homeland governments.\3\
---------------------------------------------------------------------------

    \3\ Calculation: (4 burden hours per application) x (30 foreign
homelands) x (2 requests per year) = 240 annual burden hours.
Apportioning 240 annual burden hours equally among an average of 430
applications annually = approximately 30 burden minutes per
application.
---------------------------------------------------------------------------

    We have apportioned 30 minutes to each application to account for
the time required to obtain certifications from homeland governments.
    We have no empirical data to indicate how much time is required for
a person to complete OST Form 4540; however, anecdotal evidence reveals
that respondents spend thirty (30) minutes or less completing the form
and brief justification. In some cases, respondents spend a limited
amount of time, less than ten (10) minutes, reviewing the form before
sending it via facsimile or email to the Department. In the interest of
providing a conservative estimate so as to not understate the burden
hours, we estimate the hour burden for completing OST Form 4540 as
thirty (30) minutes.

    Issued in Washington, DC on December 8, 2022.
Benjamin J. Taylor,
Director, Office of International Aviation.
[FR Doc. 2022-27072 Filed 12-13-22; 8:45 am]
BILLING CODE 4910-9X-P


MEMORANDUM

To:           The Record

Subject:  Characterization of Petroleum Refining Waste and Possible
Gasification Scenarios

In support of the final rule:  Regulation of Oil-Bearing Hazardous
Secondary Materials From the Petroleum Refining Industry Processed in a
Gasification System to Produce Synthesis Gas Fuel (Tier 3,
RIN#2050-AE78) additional analysis was conducted on a proposed condition
requiring gasification residuals to meet the Universal Treatment
Standards for six selected metals (antimony, arsenic, chromium, lead,
nickel, and vanadium).

Background

In the proposed rule, we requested comment on a condition to the
exclusion that would establish leachate limits (i.e., Universal
Treatment Standards (UTS)) for six toxic metals in the gasification
co-products and residuals prior to any placement on the land.  We
originally considered this condition to ensure that co-products and
residues generated by the gasification process that were to be placed on
the land did not contain toxic metals with a potential for leaching
greater than allowed by the requirements of the Land Disposal
Restrictions (LDR) program.  (See 67 FR at 13691, March 25, 2002.)  In
developing this possible condition, we were influenced by the condition
established for hazardous waste derived products that are used in a
manner constituting disposal (see 40 CFR 266.20).  These materials are
required to meet the appropriate LDR treatment standards prior to use as
products applied to the land (e.g., fertilizers).  We reasoned, in the
proposal, that requiring this same condition for co-products and
residuals would ensure legitimate fuel manufacturing by applying the
same land disposal provisions to the co-products and residuals that
would have existed had the material (i.e., the listed waste) not been
excluded from the definition of solid waste.  Further, we reasoned that
this proposed condition would be needed to assure that the gasification
system is operated for the purpose claimed – conversion of organic
matter in the oil-bearing hazardous secondary material into fuels (or
intermediates), while removing metals from raw synthesis gas and
trapping those metals in an inert matrix.  It was reasoned that the
levels in the proposed condition (UTS levels) would provide a means of
quantifying this premise.

We received comments that both supported and opposed this condition (See
the Response to Comment Document for a complete presentation and
discussion of all the comments on this condition).  Commenters opposed
to the condition stated that there was no need to impose the UTS
requirements beyond what the regulations (e.g., 40 CFR 261.4(a)(12)(i))
already required for residues generated from the petroleum refining
process (i.e., the characteristic test).  Commenters argued that EPA had
provided no rationale basis for imposing the additional UTS
requirements.

In response to these comments, the Agency set about reexamining the
merits of this condition.  This began with a more detailed analysis of
the characterization data for petroleum refining wastes collected as
part of the LDR program.

Characterization Data for Listed Wastes Identified as Oil-Bearing
Hazardous Secondary Materials

We reviewed data presented in several Best Demonstrated Available
Technology (BDAT) Background Documents for petroleum refining wastes to
get a better understanding of the total concentration levels of these
metals in different petroleum refining wastes.   Concentration data were
analyzed for nine listed petroleum refining wastes identified as coming
under the category of “oil-bearing hazardous secondary materials”
(Tables 1 and 2).  Next, we look at whether these six metals
constituents were part of the LDR treatment standards for the listed
oil-bearing secondary materials that would be affected by the rule
(Table 3).

Table 1 – ANALYSIS OF WASTE CHARACTERISTIC DATA

Constituents	K048	K049	K050	K051	K052	K169	K170	K171	K172	F037

K051*	F038

K048*

Water %	81	50	44	70-91.4	18	19.2	11.4	1.3	3.6	---	---

Oil and grease%	12	39	8	4.5-13	13	34.3	29.5	3.6	22	---	---

TOC %	---	---	---	---	---	23	29	4.0	7.0	---	---

Organic liquid %	---	---	---	---	---	31.8	25.7	0.5	1.0	---	---

Solids, dirt, sand %	86	10	47	16	68	54.5	69.7	98.8	97	---	---

BTU content	---	150	1500	---	---	7281	5935	1244	1684	---	---

BDAT constituent %	<1	<1	<1	<1	<1	<1	<1	<1	<1	---	---

Nickel (ppm)

Total concentration	0.025-16	9.2-86	61-170	0.25-150.4	97.2-392	15-380
62-300	66-25,000	8-14,000	12-240	<0.16-95

Nickel (TCLP)	---	---	---	---	---	---	0.2-0.52	0.91-310	0.73-67	---	---

Vanadium (ppm)

Total concentration	0.05-460	2.5-60	0.7-50	1-350	1.0-9.8	5-1,400	91-430
10-33,000	25-31,000	50-<90	50-<90

Vanadium (TCLP)	---	---	---	---	---	---	---	0.25-6.6	0.25-3.3	---	---

Table 2 – CONCENTRATION RANGES OF SELECTED METALS IN PETROLEUM
REFINERY LISTED WASTE (mg/kg) (1.)

	Antimony	Arsenic 	Chromium 	Lead 	Nickel 	Vanadium

K048	4.4 - 7	0.05 - 10.5	0.04 - 3435	0.05 - 1250	0.025 – 16	0.05 –
460

K049	BDL – 19**	<2.2 – 30***	28.9 - 1400	21.95 - 3900	9.2 – 86	2.5
– 60

K050	---	10.2 -11	11 – 1600	0.5 – 1100	61 – 170	0.7 – 50

K051	9 - 18	0.1 – 32	0.1 - 6790	0.25 - 2480	0.25 - 150.4	1 – 350

K052	111	63 – 525	1.0 - 504	11 - 5800	97.2 – 392	1.0 - 9.8

K169	<6 - 15	5.7 – 32	9.7 - 310	44 - 870	15 – 380	5 – 1400

K170	<6 - 940	<1 - 4.7	8.4 - 34	17 - 47	62 – 300	91 – 430

F037	Not Reported	ND – 61	12 - 2020	22 - 4570	12.4 – 740	Not
Reported

F038	Not Reported	0.34 - 109.4	2.5 - 2990	<1 - 3900	<0.16 – 95	Not
Reported

Composite

Range	4.4 - 940	0.05 – 525	0.04 - 6790	0.05 - 5800	0.025 – 740	0.05
– 1400

Petroleum Coke ****	---	3.53	1.3	1.5	370	1500

1.  USEPA.  Best Demonstrated Available Technology Background Document
for K048, K049, K051, K052.  August 1988; USEPA.  Best demonstrated
Available Technology Background Document for F037 and F038. 1992.
USEPA.  Best Demonstrated Available Technology Background Document for
K169-K171.  1998.

2.  If ND or BDL was reported, the next largest value was used in
determining the range.

3.  If the concentration was reported as a “less than” , the
reported value was used without the “less than” designation.

4.  Nickel and Vanadium concentration values are from: Gasification of
Petcoke Using E-Gas Technology at Wabash River, 2000.  Three
concentration values for petroleum coke were presented, the highest
value was selected for these calculations.

Table 3 – REGULATED BDAT CONSITUTENTS

	Antimony	Arsenic	Chromium	Lead	Nickel 	Vanadium

TC Levels (mg/L TCLP)	---	5.0 	5.0 	5.0	---	(not a UHC)

UTS(mg/L TCLP)	1.15	5.0	0.60	0.75	11	1.6

K048 - Dissolved air flotation (DAF) float

	X

X

	K049 - Slop oil emulsion solids

	X

X

	K050 - Heat exchange bundle cleaning sludge

	X

X

	K051 - API separator sludge

	X

X

	K052 - Tank bottoms (leaded)

	X

X

	K169 - Crude oil tank sediment

K170 - Clarified slurry oil sediment

K171 - Spent hydrotreating catalyst

X

	X	X

K172 - Spent hydrorefining catalyst	X	X

	X	X

F037 - Primary oil/water/solids separator sludge

	X

X

	F038 - Secondary oil/water/solids separator sludge

	X

X

	1)  Original treatment standard for Nickel (K048-K052) was calculated
at 0.048 mg/L TCLP based on one data point;

2)  Arsenic treatment standard is the same as TC level; and

3)  Antimony, Arsenic and Vanadium are regulated in catalysts only
(catalysts may not be suitable gasification feed).

Analysis of Petroleum Coke and Other Gasification Feedstock

We also reviewed chemical characterization data on petroleum coke as
well as other petroleum refining materials that could be used as
feedstock for gasification units (Tables 4, 5, and 6).  Refinery
feedstock suitable for gasification are often off-gas streams and
residual oils such as vacuum resid, visbreaker tar, and deasphalter
pitch.  These residuals are often referred to generically as “heavy
oils”.

The ultimate analysis of petroleum coke showed: 1) Water content ranges
from 7.0% to 12.0%; 2) Carbon content ranges from 77.7% to 81.1%; 3) BTU
value ranges from 13,360 to 14,282; 4) The concentrations of Nickel and
Vanadium (BDAT constituents) in petroleum coke are often in higher
concentrations that in the hazardous waste, except for catalysts K171
and K172.

Table 4 – PETROLEUM COKE CHARACTERIZATION DATA

	1997	1999	2000

Moisture %	7.0	12.0	7.8

Ash %	0.3	0.4	0.6

Volatiles %	12.4	11.2	10.5

Fixed Carbon%	80.4	77.7	81.1

Sulfur %	5.2	5.6	5.7

	Metals in Fuel

	Nickel, ppm	210	290	370

Vanadium, ppm	430	1500	890

Heating value (BTU/lb)	14,282	13,360	14,026

Petroleum Coke Analysis:  (Gasification of Petcoke Using E-Gas
Technology at Wabash River 2000)

Table 5 – CHARACTERIZATION DATA FOR VARIOUS FEEDSTOCK INTENDED FOR
PETROLEUM REFINING GASIFICATION

	Units	Vacuum Resid	Visbreaker Tar	Asphalt	Petcoke

Ultimate Analysis

	C	wt/wt	84.9%	86.1%	85.1%	88.6%

H

10.4%	10.4%	9.1%	2.8%

N

0.5%	0.6%	0.7%	1.1%

S

4.2%	2.4%	5.1%	7.3%

O

	0.5%

0.0%

Ash

0.0%

0.1%	0.2%

Total	wt/wt	100.0%	100.0%	100.0%	100.0%

H2/C ratio	mol/mol	0.727	0.720	0.640	0.188

Density

	Specific Gravity	60/60	1.028	1.008	1.070	0.863

API Gravity	API	6.2	8.88	0.8	---

Heating Values

	HHV(dry)	M BTU/lb	17.72	18.6	17.28	14.85

LHV(dry)	M BTU/lb	16.77	17.6	16.45	14.48

Reference:  Refinery Technology Profiles:  Gasification and Supporting
Technologies, U.S. Department of Energy, National Energy Technology
Laboratory, Energy Information Administration, June 2003

Table 6 – ANALYSIS OF EL DORADO GASIFIER FEEDSTOCK

	Petroleum Coke	Recycled Filter Cake (1.)	Fluxing Additive	Acid Soluble
Oil	API Separator Bottoms	Primary Sludge	Phenolic Residue

D001,D018	K051 (2.)	F037, F038 (3.)	K022 (4.)

Moisture (as received),wt%	5-10	50	5	1.4	20-75	20	0.8

Heating Value (dry), BTU/lb	15,400	13,000	0	18,900	6,300	<1,000	15,700

Ultimate Analysis (dry) Wt%

	Carbon	89.5	88.9	---	86.4	32.8	0-5	82.7

Hydrogen	3.9	0.1	---	12.0	4.3	---	7.4

Nitrogen	1.3	0.7	---	0.02	0.5	---	0.1

Sulfur	4.7	2.4	---	0.3	2.7	---	0.01

Ash	0.4	7.9	100	0.4	57.6	95-100	0.2

1.  This is the unconverted carbon from the gasifier recovered in a
gravity settler and dewatered by rotary vacuum filtration.  It’s
non-hazardous and non-leachable through testing.  Although it has a high
BTU value no buyer has been found, it’s another low value item for the
refinery and recycled back into gasifier.

2.  The refinery’s delayed coker is also capable of processing API
separator bottoms.

3.  The gasifier was not designed to handle the entire refinery
production of primary sludge.  The design intent was to gasify all the
available API separator bottoms and then gasify as much sludge as
possible.  The refinery’s delayed coker is also capable of processing
primary sludge.

4.  Distillation bottom tars from the production of phenol/acetone from
cumene.

Experience with Low Value Feed Gasification at the El Dorado, Kansas
Refinery by Gary DelGrego, Texaco Power and Gasification.  Presented at
the 1999 Gasification Technologies Conference.

Results of Biennial Report Analysis

Generation Rates

Potential generation rates of oil-bearing hazardous secondary materials
were derived from the 2003 Biennial Report, using the following waste
codes: K048-K052, K169-K172, F037 and F038 representing oil-bearing
hazardous secondary materials.  The BRS reported 324,371 tons of
oil-bearing hazardous secondary materials generated by 153 sites (SIC
2811).  The average generation rate was calculated at 2,314 tons/year,
with a maximum generation rate of 76,582 tons/year and a minimum of less
than 1 ton/year.  Over 82 facilities generate over 10,000 tons/year

Management

144,012 tons of oil-bearing hazardous material was managed by material
recovery (primarily metal catalysts); 25,457 tons went to energy
recovery (cement kilns, BTU >5000); 92,658 tons to incineration; 17,495
tons to other treatment (sludge treatment, stabilization,
macro-encapsulation); 23,352 tons to disposal (land treatment, landfill,
and deepwell injection); and 21,396 tons went to other management
(unknown management, fuel blending, storage/bulking/transfer).

Possible Gasification Scenarios Utilizing Oil-bearing Hazardous
Secondary Material With Petroleum Coke

Based on all this information, the following possible refining scenarios
utilizing gasification were developed, demonstrating that oil-bearing
hazardous secondary materials (low-value fuels) could supplement the
petroleum coke feed on a very limited basis.  It should be noted
however, that to date, no information has been discovered that would
suggest that this type of activity is being pursued.

As an example, consider a 1000 TPD gasification unit being employed at a
petroleum refinery producing 1000 TPD petroleum coke.  The facility also
produces 2000 TPY of oil-bearing hazardous secondary material.  If the
gasification system is fed the oil-bearing hazardous secondary material
at 10% of the total feed (900 TPD petroleum coke, 100 TPD supplemental
feed).  The supplemental feed will be depleted in 20 days.  If you
reduce the feed to 5%, the supplemental feed is depleted in 40 days, and
1%, the supplemental feed is depleted in 200 days.

As a second example, consider a 2000 TPD gasification unit.  The
petroleum refinery produces 1800 TPD of petroleum coke, and 10,000 TPY
of oil-bearing hazardous secondary material.  If the gasification system
is fed the oil-bearing hazardous secondary material at a rate of 10% of
the total feed (1800 TPD petcoke; 200 TPD supplemental) the supplemental
feed will be depleted in 50 days.  Reduce the feed to 5%, it is depleted
in 100 days; and reduce to 1%, the feed is depleted in 500 days.

These examples suggest that oil-bearing hazardous secondary material can
be introduced, on a limited basis, into a gasification system with
petroleum coke.

The following table is derived from the Gasification Technology
Council’s website and presents information on various gasification
units operating in the United States.   The information presented on the
future gasifier planned for the BP facility in Carson City, California
was found on the BP website.

Table 6 – GASIFICATION SYSTEMS USING PETROLEUM COKE AND/OR REFINERY
WASTE AS FEED

Facility	Feed	Status(2004)

Frontier

El Dorado, Kansas	150.60 mt/d petcoke

13.6 mt/d refinery waste

7,000 mm BTU/d 	Operating

ExxonMobil Chemical

Baytown, Texas	1,000 mt/d deasphalter pitch	Operating

Coffeyville Resources Refining and Marketing

Coffeyville, Kansas	1,100 mt/d petcoke	Operating

Eastman Chemical

Kingsport, Tennessee	1,225 t/d coal	Operating

Wabash

West Terre Haute, Indiana	2,000 mt/d petcoke	Operating

Premcor

Wilmington, Delaware	2,100 mt/d petcoke	Operating

Vanguard

Louisiana	2,700 mt/d petcoke	Startup 2008

BP

Carson, California	4,500 TPD petcoke	Startup 2011

Cost $1 billion

CITGO

Lake Charles, Louisiana	7,000 mt/d petcoke	Startup 2009

Great Plains

Beulah, North Dakota	14,000 t/d coal

50.00 t/d refinery waste	Operating

From:    HYPERLINK "http://www.gasification.org"  www.gasification.org
and www.bp.com

Future Trends in Petroleum Refining Gasification

Information from the DOE report, Refinery Technology Profiles:
Gasification and Supporting Technologies. US DOE, National Energy
Technology Laboratory.  June 2003, suggests that growth in petroleum
refinery gasification will most likely be driven by future supply and
demand of petroleum coke.  (Coking capacity has grown by 60% over last
decade, trend is expected to continue but at a slower rate.).  There are
40 refineries (out of 153) within the U.S. (located in California,
Texas, and Louisiana) that produce sufficient quantities of petroleum
coke(>1000 TPD) to be considered candidates for the addition of
petroleum coke gasification at the petroleum refinery.  These 40
facilities account for 98% of total volume of petroleum coke generated
in the U.S.  Simple economic payback estimated at 4-5 years. Market
penetration rate of possibly one plant every two years would not seem
unreasonable.  This would result in 7 to 9 plants by 2010 and as many as
17 plants by 2025.  Gasification plant capacities of 1,000 to 2,000 TPD
typical, however the two planned facilities are over 5,000 TPD
(Louisiana and Texas).  This coincides with the amount of petroleum coke
currently generated at the facilities.

Both waste characterization data and data on waste generation rates
suggest that industry would probably not build a gasification unit
dedicated to the gasification of oil-bearing hazardous secondary
materials.  However, smaller gasification units are still being explored
for possible application at petroleum refineries, and as part of this
analysis have been evaluated.  Given, existing information and current
gasification patterns, that the most probable gasification scenario,
however, is that a petroleum refinery will build a gasification unit for
petroleum coke gasification with oil-bearing hazardous secondary
material possibly used as a supplemental feed.  As suggested in the DOE
report, gasifiers will most likely be built at petroleum refineries that
generate >1000 TPD of petroleum coke.  There are approximately 40
refineries located in California, Texas, and Louisiana that generate
that quantity of petroleum coke.  Available information on existing
gasification units suggest that if oil-bearing hazardous secondary
material is used as a supplemental feedstock, it could make-up between
0.1 to 10% of the total feed (This range is derived by using the lowest
(Dakota Gasification) input, on a percentage basis of oil-bearing
hazardous secondary material and highest (El Dorado) input of
oil-bearing hazardous secondary material in combination with petroleum
coke or coal to a gasification unit.)  Total BDAT constituents (metals
and organics) in listed refinery wastes account for less than 1% total
composition of the waste. Petroleum coke will dominate residual
composition.

The DOE report indicates that no new gasification systems will come
on-line until 2008 and possibly only 3 by 2011, and that these
gasification systems will be designed for processing petroleum coke.
Oil-bearing secondary materials (low value fuels) could supplement the
petroleum coke feed on a very limited basis. However, no information has
been presented to suggest this is what will occur.   (Note:  These
predictions appear to be optimistic based on current information
available to the Agency).

We developed various scenarios for feeding petroleum coke to a
gasification system to estimate TCLP concentrations of selected metals
in the gasification bottoms.  As part of this analysis we made several
assumptions:  1) The concentration of selected metals in the secondary
feed is given as a “composite range” of the listed petroleum
refining wastes K048-K052, K169-K170 and F037-F038;  2)  171 and K172
wastes are catalysts from petroleum refining operations and are not used
as part of the “composite range” because of its low carbon and high
metal content; and 3) 100% of the metals will partition to the
gasification bottoms.  With these assumptions we developed several
gasification scenarios.

Scenario 1:  A 2000 MTD gasification system feeding 100% petroleum coke.

Scenario 2:  A 2000 MTD gasification system feeding 90% petroleum coke
and 10% of a refining waste composite using a lower bound and upper
bound analysis for selected metal concentrations in the composite
petroleum refining waste.  This represents a gasification scenario with
a maximum input of oil-bearing hazardous secondary material in
combination with petroleum coke.

Scenario 3:  A 20 MTD gasification system feeding 100% of a refining
waste composite using a lower bound, mean of the composite range and
upper bound analysis for selected metal concentrations.

Scenarios 4 and 5:  A 20 MTD gasification system feeding 100% of a
refining waste composite using a lower bound, mean of the composite
range  and upper bound analysis for selected metal concentrations, where
50% and 80% of the feed partitions to the gasifier bottoms.

Selected Gasification Scenarios:

Scenario 1:

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

2000 MTD Gasifier Feeding 100% Petroleum Coke

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	 ---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.60	0.75	11	1.6

Concentration in Petroleum Coke (mg/kg)	---	3.53	1.3	1.5	370	1500

Total Concentration of Metal in Bottoms (mg/kg)	---	35.3	13	15	3700
15000

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	---	1.76	0.65	0.75	185	750

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by 0.001)	---	0.0353	0.013	0.015	3.7	15

Sample Calculation – Method 1 (Arsenic):

2000 MT (3.53/10E6) = 0.00706 MT of Arsenic

0.00706 MT of Arsenic/200 MT of bottoms = 0.0000353 x 10E6 = 35.3 mg/kg
Arsenic in bottoms

(35.3)(.05) = 1.76 mg/L TCLP

(35.3)(.001) = 0.0353 mg/L TCLP

Sample Calculation – Method 2 (Arsenic):

(2000 MT)(1000 kg/MT) = 2,000,000 kg of petroleum coke

(2,000,000 kg)(3.53mg Arsenic/kg) = 7,060,000 mg Arsenic

7,060,000 mg Arsenic/(200 MT)(1000kg/MT) = 35.3 mg/kg Arsenic in
gasifier bottoms

(35.3)(.05) = 1.76 mg/L TCLP

(35.3)(.001) = 0.0353 mg/L TCLP

Scenario 2:

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

2000 MTD Gasifier Feeding 90% Petroleum Coke/10% Petroleum Waste
Composite

LOWER BOUND

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	 ---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.60	0.75	11	1.6

Lower Bound

Petroleum Waste Composite (mg/kg)	4.4 	0.05  	0.04 	0.05 	0.025	0.05

Concentration in Petroleum Coke (mg/kg)	---	3.53	1.3	1.5	370	1500

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	---	31.8	11.54
13.55	3330.025	13500

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	---	1.59	0.577	0.6775	166.50	675.0

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by 0.001)	---	0.0318	0.01154	0.01355	3.33	13.5

UPPER BOUND

Upper Bound

Petroleum Waste Composite(mg/kg)	940	525	6790	5800	740	1400

Concentration in Petroleum Coke (mg/kg)	---	3.53	1.3	1.5	370	1500

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	---	556.77
6801.7	5813.5	4070	14900

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	---	27.84	340.1	290.7	203.5	745

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by 0.001)	---	0.557	6.8	5.81	4.1	14.9

Sample Calculation – Method 1 (Arsenic):

(1800 MT of petcoke)(3.53/10E6) + (200 MT of secondary material)
(0.05/10E6) = 0.006354 + .00000005 = .00635405/200tons x 10E6 = 31.77 =
31.8 mg/kg Arsenic in bottoms

Application of 20:1 ratio from TCLP (multiply by 0.05):  31.77 x .05 =
31.8 x 0.05 = 1.59 mg/L TCLP

Application of 1000:1 ratio from TCLP (multiply by 0.001):  31.77 x .001
= 31.8 x 0.001 = 0.0318 mg/L TCLP

Sample Calculation – Method 2 (Arsenic)

(1800 MT of petroleum coke)(1000kg/MT) = 1.8 x 10E6 kg petroleum coke
 (200 MT of secondary material)(1000kg/MT) = 2.0 x 10E5 kg secondary
material.

(1.8 x 10E6 kg petroleum coke)(3.53 mg Arsenic in petroleum coke/kg) =
6.3 54x 10E6 mg Arsenic

(2.0 x 10E5 kg secondary material)(0.05 mg Arsenic/kg secondary
material) = 1 x 10E4 mg Arsenic

6.354 x 10E6 mg Arsenic +.01 x 10 E6 mg Arsenic = 6.364 x 10E6 mg
Arsenic

200 MT of gasifier bottoms

6.364 x 10E6/(200MT)(1000 kg/MT) = 31.8 mg/kg Arsenic in bottoms.

Application of 20:1 ratio from TCLP (multiply by 0.05):  31.8 x .05 =
1.59 mg/L TCLP

Application of 1000:1 ratio from TCLP (multiply by 0.001):  31.8 x 0.001
= 0.0318 mg/L TCLP

Scenario 3:

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

20 MTD Gasifier Feeding 100% Petroleum Waste With 10% of Mass to
Gasifier Bottoms

LOWER BOUND

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.6	0.75	11	1.6

Lower Bound

Waste Composite (mg/kg)	4.4	0.05	0.04	0.05	0.025	0.05

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	44	0.5	0.4	0.5
0.25	0.5

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	2.2	0.025	0.02	0.025	0.0125	0.025

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.044	0.0005	0.0004	0.0005	0.00025	0.0005

UPPER BOUND

Upper Bound

Waste Composite (mg/kg)	940	525	6790	5800	740	1400

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	9400	5250	67900
58000	7400	14000

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	470	262.5	3395	2900	370	700

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	9.4	5.25	67.9	58	7.4	14

Sample Calculation (Antimony):

(20 MT)(1000kg/MT) = 20,000 kg waste

(20,000 kg waste)(4.4 mg/kg) =88000 mg Antimony

In 20 MTD gasifiers 90% mass goes to syngas; 10% to bottoms with 100% of
metals

Therefore; 2 MTD of bottoms generated.

88000 mg Antimony/(2 MT)(1000kg/MT) = 44 mg/kg of Antimony

Apply 20:1 TCLP ratio (multiply by 0.05) = 2.2 mg/L TCLP

Apply 1000:1 (multiply by 0.001) = 0.044 mg/L TCLP

Scenario 4

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

20 MTD Gasifier Feeding 100% Petroleum Waste With 50% of Mass to
Gasifier Bottoms

LOWER BOUND

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.6	0.75	11	1.6

Lower Bound

Waste Composite (mg/kg)	4.4	0.05	0.04	0.05	0.025	0.05

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	8.8	0.1	0.08
0.1	0.05	0.1

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	0.44	0.005	0.004	0.005	0.0025	0.005

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.0088	0.0001	0.00008	0.0001	0.00005	0.0001

MEAN OF THE COMPOSITE RANGE

Mean of the Composite Range (mg/kg)	472.2	262.5	3395	290	370	700

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	944	525	6790
580	740	1400

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	47.22	26.25	339.5	29	37	70

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.944	0.525	6.79	0.58	0.74	1.4

UPPER BOUND

Upper Bound

Waste Composite (mg/kg)	940	525	6790	5800	740	1400

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	1880	1050	13580
11600	1480	2800

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	94	52.5	679	580	74	140

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	1.88	1.05	13.58	11.6	1.48	2.8

Sample Calculation (Antimony):

(20 MT)(1000kg/MT) = 20,000 kg waste

(20,000 kg waste)(940 mg/kg) =18,800,000 mg Antimony

In 20 MTD gasifiers 50% mass goes to syngas; 50% to bottoms with 100% of
metals

Therefore; 10 MTD of bottoms generated.

18,800,000 mg Antimony/(10 MT)(1000kg/MT) = 1880 mg/kg of Antimony

Apply 20:1 TCLP ratio (multiply by 0.05) = 94 mg/L TCLP;   Apply 1000:1
(multiply by 0.001) =  1.88 mg/L TCLP

Scenario 5

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

20 MTD Gasifier Feeding 100% Petroleum Waste With 80% of Mass to
Gasifier Bottoms

LOWER BOUND

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.6	0.75	11	1.6

Lower Bound

Waste Composite (mg/kg)	4.4	0.05	0.04	0.05	0.025	0.05

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	5.5	0.0625	0.05
0.0625	0.03125	0.0625

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	0.275	0.0031	0.0025	0.0031	0.0016	0.0031

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.0055	0.0000625	0.00005	0.0000625	0.000031	0.000625

MEAN OF THE COMPOSITE RANGE

Mean of the Composite Range (mg/kg)	472.2	262.5	3395	290	370	700

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	590.25	328.125
4243.75	362.5	462.5	875

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	29.5	16.4	212.2	18.12	23.12	43.75

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.59	0.328	4.24	0.3625	0.462	0.875

UPPER BOUND

Upper Bound

Waste Composite (mg/kg)	940	525	6790	5800	740	1400

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	1175	656.25
8487.5	7250	925	1750

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	58.75	32.81	424.37	362.5	46.25	87.5

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	1.175	0.656	8.48	7.25	0.925	1.750

Sample Calculation (Antimony):

(20 MT)(1000kg/MT) = 20,000 kg waste

(20,000 kg waste)(940 mg/kg) =18,800,000 mg Antimony

In 20 MTD gasifiers 20% mass goes to syngas; 80% to bottoms with 100% of
metals

Therefore; 16 MTD of bottoms generated.

18,800,000 mg Antimony/(16 MT)(1000kg/MT) = 1175 mg/kg of Antimony

Apply 20:1 TCLP ratio (multiply by 0.05) = 58.75 mg/L TCLP; Apply 1000:1
(multiply by 0.001) =  1.175 mg/L TCLP

Analysis of Gasification Scenarios

Nickel (370 mg/kg) and Vanadium (1500mg/kg) concentrations found in
petroleum coke will dominate TCLP results in 2000 MTD gasification
scenarios.  The upper bound scenarios for Chromium and Lead are based on
characterization data not reflective of overall reduction in the use of
these metals throughout the refinery industry.   Under LDRs, only
Chromium and Nickel would be regulated as “constituents of concern”
in these wastes.

Two gasification scenarios were developed that represented
“extremes” for gasification activities that could be conducted at
petroleum refineries.  The first scenario was a large gasification
system ( i.e., 2000 MT/day) utilizing  a feedstock comprised of 90%
petroleum coke and 10% oil-bearing hazardous secondary material (this is
consistent with the largest feedrate for oil-bearing hazardous secondary
material gasified at a petroleum refinery) and a small gasifer dedicated
to processing 100% of oil-bearing hazardous secondary material.  As a
result of this analysis, we concluded, that gasification residuals would
achieve the UTS levels for all metals, except for vanadium in one
scenario (2000 MT/day) and chromium(20 MT/day) in the other.  With
regard to chromium the concentration level was below the characteristic
level, but above the UTS level.  As for vanadium, it was determined that
petroleum coke (a product) contributed most of the vanadium to the
gasifier, and that vanadium concentrations in the gasification residuals
would not be affected when feeding petroleum coke alone or in
combination with oil-bearing hazardous secondary materials.

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

2000 MTD Gasifier Feeding 90% Petroleum Coke/10% Petroleum Waste
Composite

LOWER BOUND

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	 ---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.60	0.75	11	1.6

Lower Bound

Petroleum Waste Composite (mg/kg)	4.4 	0.05  	0.04 	0.05 	0.025	0.05

Concentration in Petroleum Coke (mg/kg)	---	3.53	1.3	1.5	370	1500

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	---	31.8	11.54
13.55	3330.025	13500

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	---	1.59	0.577	0.6775	166.50	675.0

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by 0.001)	---	0.0318	0.01154	0.01355	3.33	13.5

As generated, the gasifier bottoms will not be characteristic and will
meet the UTS for all metals except vanadium.

TCLP Concentration Estimates for Selected Metals in Gasifier Bottoms

20 MTD Gasifier Feeding 100% Petroleum Waste With 80% of Mass to
Gasifier Bottoms

MEAN OF THE COMPOSITE RANGE

	Antimony	Arsenic	Chromium	Lead	Nickel	Vanadium

Characteristic Level (mg/L TCLP)	---	5.0	5.0	5.0	---	---

UTS (mg/L TCLP)	1.15	5.0	0.6	0.75	11	1.6

Mean of the Composite Range (mg/kg)	472.2	262.5	3395	290	370	700

Total Concentration of Metal in Gasifier Bottoms (mg/kg)	590.25	328.125
4243.75	362.5	462.5	875

TCLP Concentration in Gasifier Bottoms Using 20:1 Ratio (mg/L) (multiply
by 0.05)	29.5	16.4	212.2	18.12	23.12	43.75

TCLP Concentration in Gasifier Bottoms Using 1000:1 Ratio (mg/L)
(multiply by .001)	0.59	0.328	4.24	0.3625	0.462	0.875

As generated, the gasifier bottoms will not be characteristic and will
meet the UTS for all metals except chromium.

Although this analysis showed chromium levels above the UTS in one
scenario, the Agency is convinced that chromium concentrations in
oil-bearing hazardous secondary materials have decreased from the levels
found in our characterization studies, which were written in 1988, 1992,
and 1998, and therefore will be lower than what we used in our analysis
(i. e., the gasification residuals will have concentration levels below
the UTS.)  This is based on information in the preamble for the August
1998 listing rule promulgating the exclusion at 40 CFR 261.4(a)(12)(i)
that indicates that chromium levels in these hazardous secondary
materials will decrease due to a prohibition on chromium-based water
treatment chemicals in industrial cooling towers as a result of Clean
Air Act requirements, see 450 CFR Part Subpart Q (On September 8, 1994
(59 FR 46339), EPA issued a final MACT rule that eliminated the use of
chromium-based treatment chemicals and subsequently chromium compound
emissions from industrial cooling towers.)

   USEPA.  Best Demonstrated Available Technology Background Document
for K048, K049, K051, K052.  August 1988; USEPA.  Best demonstrated
Available Technology Background Document for F037 and F038. 1992.
USEPA.  Best Demonstrated Available Technology Background Document for
K169-K171.  1998.

 Petroleum Listing (1998):  “EPA also believes that the lead and
chromium in the secondary materials should decline with time.  This is
due to overall reduction in the use of these metals throughout the
refinery (e.g., leaded gasoline is no longer produced on a wide-scale
and chromium-based water treatment chemicals are no longer used in
industrial cooling towers, as a result of Clean Air Act requirements,
see 40 CFR Part 63, Subpart Q).”

 PAGE

 PAGE   1


[Federal Register: March 1, 2006 (Volume 71, Number 40)]
[Rules and Regulations]
[Page 10438-10439]
[DOCID:fr01mr06-8]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9, 156 and 165

[EPA-HQ-OPP-2005-0327; FRL-7749-1]
RIN 2070-AB95

Pesticide Management and Disposal; Standards for Pesticide
Containers and Containment; Notification to the Secretary of
Agriculture

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notification to the Secretary of Agriculture.

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

SUMMARY: This document notifies the public that the Administrator of
EPA has forwarded to the Secretary of Agriculture a draft final rule as
required by section 25(a) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). As described in the Agency's semi-annual
Regulatory Agenda, the draft final rule would establish standards for
removal of pesticides from containers and for rinsing containers;
facilitate the safe use, refill, reuse, and disposal of pesticide
containers by establishing standards for container design, labeling and
refilling; and establish requirements for containment of large,
stationary pesticide containers and for containment of pesticide
dispensing areas.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-HQ-OPP-2005-0327. All documents in the docket are listed on the
http://www.regulations.gov web site. Although listed in the index, some

information is not publicly available, e.g., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the Internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at the

Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA, Monday
through Friday, excluding legal holidays. The Docket telephone number
is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Nancy Fitz, Field and External Affairs
Division, (7506C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. It simply
announces the submission of a draft final rule to USDA and does not
otherwise affect any specific entities. This action may, however, be of
particular interest to pesticide formulators, agrichemical dealers, and
independent commercial pesticide applicators. Since other entities may
also be interested, the Agency has not attempted to describe all the
specific entities that may be interested in this action. If you have
any questions regarding this action, consult the person listed under
FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other
Related Information?

    In addition to using http://www.regulations.gov, you may access

this Federal Register document electronically through the EPA Internet
under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 is

available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

II. What Action is EPA Taking?

    Section 25(a)(2) of FIFRA requires the Administrator to provide the
Secretary of Agriculture with a copy of any final regulation at least
30 days before signing it for publication in the Federal Register. The
draft final rule is not available to the public until after it has been
signed by EPA. If the Secretary comments in writing regarding the draft
final rule within 15 days after receiving it, the Administrator shall
include the comments of the Secretary, if requested by the Secretary,
and the Administrator's response to those comments in the final rule
when published in the Federal Register. If the Secretary does not
comment in writing within 15 days after receiving the draft final rule,
the Administrator may sign the final rule for publication in the
Federal Register anytime after the 15-day period.

III. Do Any Statutory and Executive Order Reviews Apply to this
Notification?

    No. This document is not a rule, it is merely a notification of
submission to the Secretary of Agriculture. As such, none of the
regulatory assessment requirements apply to this document.

IV. Will this Notification be Subject to the Congressional Review Act?

    No. This action is not a rule for purposes of the Congressional
Review Act (CRA), 5 U.S.C. 804(3), and will not be submitted to
Congress and the Comptroller General. EPA will submit the final rule to
Congress and the Comptroller General as required by the CRA.

List of Subjects

Part 9

    Environmental protection, Reporting and recordkeeping requirements.

Part 156

    Environmental protection, Labeling, Pesticides and pests.

Part 16

    Environmental protection, Packaging and containers, Containment
structures, Pesticides and pests.

    Dated: February 9, 2006.
James Jones,
Director, Office of Pesticide Programs.
[FR Doc. 06-1853 Filed 2-28-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Notices]
[Pages 53476-53478]
[FR Doc No: 2018-23058]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and
FDA-2017-E-5944]

Determination of Regulatory Review Period for Purposes of Patent
Extension; SILIQ

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for SILIQ and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by
December 24, 2018. 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 April 22, 2019. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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 Nos.
FDA-2017-E-5940, FDA-2017-E-5941, FDA-2017-E-5943, and FDA-2017-E-5944
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; SILIQ.'' Received comments, those filed in a timely manner
(see ADDRESSES), 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 Sec.  10.20 (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.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    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 human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, 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 human biological product will include all the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product SILIQ
(brodalumab). SILIQ is indicated for treatment of moderate to severe
plaque psoriasis in adult patients who are candidates for systemic
therapy or phototherapy and have failed to respond or have lost
response to other systemic therapies. Subsequent to this approval, the
USPTO received patent term restoration applications for SILIQ (U.S.
Patent Nos. 7,767,206; 7,939,070; 8,435,518; and 8,545,842) from Kirin-
Amgen, Inc., and the USPTO requested FDA's assistance in determining
the patents' eligibility for patent term restoration. In a letter dated
January 9, 2018, FDA advised the USPTO that this human biological
product had undergone a regulatory review period and that the approval
of SILIQ represented the first permitted commercial marketing or use of
the

product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
SILIQ is 3,101 days. Of this time, 2,643 days occurred during the
testing phase of the regulatory review period, while 458 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 22,
2008. The applicant claims September 26, 2009, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was August 22, 2008,
which was 30 days after FDA receipt of an earlier IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): November 16, 2015. FDA has verified the
applicant's claim that the biologics license application (BLA) for
SILIQ (BLA 761032) was initially submitted on November 16, 2015.
    3. The date the application was approved: February 15, 2017. FDA
has verified the applicant's claim that BLA 761032 was approved on
February 15, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,156 days, 906 days, or 847 days of patent term
extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: October 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23058 Filed 10-22-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26060-26062]
[FR Doc No: 2018-12027]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1922]

Formal Meetings Between the Food and Drug Administration and
Sponsors or Applicants of Biosimilar User Fee Act Products; 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 ``Formal
Meetings Between the FDA and Sponsors or Applicants of BsUFA
Products.'' This draft guidance provides recommendations to industry on
formal meetings between FDA and sponsors or applicants relating to the
development and review of biosimilar or interchangeable biological
products regulated by the Center for Drug Evaluation and Research
(CDER) or the Center for Biologics Evaluation and Research (CBER). The
previous guidance for industry entitled ``Formal Meetings Between the
FDA and Biosimilar Biological Product Sponsors or Applicants,'' issued
on November 18, 2015, has been withdrawn.

DATES: Submit either electronic or written comments on the draft
guidance by September 4, 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-1922 for ``Formal Meetings Between the Food and Drug
Administration and Sponsors or Applicants of Biosimilar User Fee Act
Products; Draft Guidance for Industry; Availability.'' 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: Neel Patel, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6468, 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 ``Formal Meetings Between the FDA and Sponsors or Applicants
of BsUFA Products.'' This draft guidance provides recommendations to
industry on formal meetings between FDA and sponsors or applicants
relating to the development and review of biosimilar or interchangeable
biological products regulated by CDER or CBER. This draft guidance does
not apply to meetings associated with the development of products
intended for submission in, or review of, new drug applications or
abbreviated new drug applications under section 505 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), biologics license applications
under section 351(a) of the Public Health Service Act, or submissions
for devices under the FD&C Act. For the purposes of this draft
guidance, formal meeting includes any meeting that is requested by a
sponsor or applicant following the procedures provided in this draft
guidance and includes meetings conducted in any format (i.e., face to
face, teleconference/videoconference, written response only).
    The Biosimilar User Fee Act of 2012 (BsUFA I) added sections 744G
and 744H to the FD&C Act, authorizing FDA to collect user fees for a 5-
year period for biosimilar biological products. BsUFA was reauthorized
for a 5-year period in 2017 under Title IV of the FDA Reauthorization
Act of 2017 (BsUFA II), enacted on August 18, 2017. In conjunction with
that reauthorization, FDA agreed to specific performance goals and
procedures described in the document, ``Biosimilar Biological Product
Reauthorization Performance Goals and Procedures Fiscal Years 2018
Through 2022'' (BsUFA II goals letter available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf). The BsUFA II goals letter includes meeting management
goals for formal meetings that occur between the FDA and sponsors or
applicants.
    In the BsUFA II goals letter, FDA committed to issuing this draft
guidance. This draft guidance discusses the principles of good meeting
management practices and describes standardized procedures for
requesting, preparing, scheduling, conducting, and documenting formal
meetings between FDA and sponsors or applicants of BsUFA products.
    The previous guidance for industry entitled ``Formal Meetings
Between the FDA and Biosimilar Biological Product Sponsors or
Applicants,'' issued on November 18, 2015, has been withdrawn.
    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 formal
meetings between the FDA and sponsors or applicants of BsUFA products.
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
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information referred to in the guidance for
industry entitled ``Formal Meetings Between the FDA and Biosimilar
Biological Product Sponsors or Applicants'' have been approved under
OMB control number 0910-0802. The collections of information in 21 CFR
part 312 have been approved under OMB control number 0910-0014 and
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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: May 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12027 Filed 6-4-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 162 (Wednesday, August 23, 2017)]
[Notices]
[Page 40005]
[FR Doc No: 2017-17783]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2464]

Advancing the Development of Pediatric Therapeutics: Application
of ``Big Data'' to Pediatric Safety Studies; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Office of Pediatric Therapeutics, Food and Drug
Administration (FDA), is announcing a public workshop entitled
``Advancing the Development of Pediatric Therapeutics (ADEPT):
Application of ``Big Data'' to Pediatric Safety Studies.'' The purpose
of this 2-day workshop is to understand how to access and analyze ``Big
Data'' associated with safety information in the health care setting,
and the utility and challenges associated with the use of ``Big Data''
to study the safety of therapeutics in children.

DATES: The public workshop will be held on September 18 and 19, 2017,
from 8:30 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at the DoubleTree by Hilton
Hotel, 8727 Colesville Rd. (Route 29), Silver Spring, MD 20910.

FOR FURTHER INFORMATION CONTACT: Renan A. Bonnel, Office of Pediatric
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, Fax:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Large volumes of data in the context of the health care industry
have the potential to provide additional information related to
medication use, which may affect the benefit-risk assessment of
medicines in general and pediatric medicines in particular. Since
pediatric pharmacoepidemiologic studies tend to enroll fewer patients
than adult studies, additional information may be needed to better
understand the safety and efficacy of use of these drugs in children.
``Big Data'', including forms of real world evidence that may involve
large and complex data sets, may be particularly useful as a supplement
to traditional studies. Supplementary information may include
additional clinical trial data, registry data, and electronic health
record information.

II. Topics for Discussion at the Public Workshop

    In this workshop, FDA will gather information on the latest
developments in ``Big Data'' from the perspective of a number of
stakeholders and expand the conversation to include the utility and
challenges associated with the use of ``Big Data'' in the pediatric
setting. Day 1 will focus on national and international uses of ``Big
Data'' in health care. Day 2 will focus on ``Big Data'' utility in the
pediatric setting, including specific challenges associated with
pediatric data.

III. Participation in the Public Workshop

    Registration: Persons interested in attending this workshop must
register online at: https://www.eventbrite.com/e/public-workshop-advancing-the-development-of-pediatric-therapeutics-adept-application-of-big-data-tickets-32470264435 by August 22, 2017. For those without
internet access, please contact Renan A. Bonnel (see FOR FURTHER
INFORMATION CONTACT) to register.
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by August 22, 2017. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants.
    Registration information, the agenda, and additional background
materials can be found at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm545847.htm.
    If you need special accommodations due to a disability, please
contact Renan A. Bonnel (see FOR FURTHER INFORMATION CONTACT) at least
7 days in advance. Persons attending the meeting are advised that FDA
is not responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast.
    September 18: Login URL: https://event.webcasts.com/starthere.jsp?ei=1144352 (morning session).
    After the morning session, users will be automatically redirected
to the afternoon link. Should you lose connection over lunch, please
use the following link for the afternoon session (Note: the link for
the afternoon session is different from the morning session): Login
URL: https://event.webcasts.com/starthere.jsp?ei=1144354 (afternoon
session).
    September 19: Login URL: https://event.webcasts.com/starthere.jsp?ei=1144356 (morning session).
    After the morning session, users will be automatically redirected
to the afternoon link. Should you lose connection over lunch, please
use the following link for the afternoon session (Note: the link for
the afternoon session is different from the morning session): Login
URL: https://event.webcasts.com/starthere.jsp?ei=1144357 (afternoon
session).
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
office (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. A link to the transcript will be available
on the internet at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm545847.htm.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17783 Filed 8-22-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 235 (Tuesday, December 8, 2015)]
[Notices]
[Pages 76332-76333]
[FR Doc No: 2015-30838]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Investment Advisers Act of 1940, Release No. 4285/December 2,
2015; Notice of Intention To Cancel Registrations of Certain Investment
Advisers Pursuant to Section 203(H) of the Investment Advisers Act of
1940

    Notice is given that the Securities and Exchange Commission (the
``Commission'') intends to issue an order or orders, pursuant to
Section 203(h) of the Investment Advisers Act of 1940 (the ``Act''),
cancelling the registrations of the investment advisers whose names
appear in the attached Appendix, hereinafter referred to as the
registrants.
    Section 203(h) of the Act provides, in pertinent part, that if the
Commission finds that any person registered under Section 203, or who
has pending an application for registration filed under that section,
is no longer in existence, is not engaged in business as an investment
adviser, or is prohibited from registering as an investment adviser
under section 203A, the Commission shall by order, cancel the
registration of such person.
    The registrants listed in the Appendix either have not filed a Form
ADV amendment with the Commission as required by rule 204-1 under the
Act and appear to be no longer in business as investment advisers, or
have indicated on Form ADV that they are no longer eligible to remain
registered with the Commission as investment advisers but have not
filed Form ADV-W to withdraw their registration. Accordingly, the
Commission believes that reasonable grounds exist for a finding that
these registrants are no longer in existence, are not engaged in
business as investment advisers, or are prohibited from registering as
investment advisers under section 203A of the Act, and that their
registrations should be cancelled pursuant to section 203(h) of the
Act.
    Notice is also given that any interested person may, by Monday,
December 28, 2015, at 5:30 p.m., submit to the Commission in writing a
request for a hearing on the cancellation of a registrant, accompanied
by a statement as to the nature of the writer's interest, the reason
for such request, and the issues, if any, of fact or law proposed to be
controverted, and the writer may request to be notified if the
Commission should order a hearing thereon. Any such communication
should be addressed: Secretary, Securities and Exchange Commission,
Washington, DC 20549.
    At any time after Monday, December 28, 2015, the Commission may
issue an order or orders cancelling the registrations of any or all of
the registrants listed in the Appendix, upon the basis of the
information stated above, unless an order or orders for a hearing on
the cancellation shall be issued upon request or upon the Commission's
own motion. Persons who requested a hearing, or to be advised as to
whether a hearing is ordered, will receive any notices and orders
issued in this matter, including the date of the hearing (if ordered)
and any postponements thereof. Any adviser whose registration is
cancelled under delegated authority may appeal that decision directly
to the Commission in accordance with rules 430 and 431 of the
Commission's rules of practice (17 CFR 201.430 and 431).
    For further information contact: Jamie Lynn Walter, Senior Counsel
at<PHONE_NUMBER> (Division of Investment Management, Office of
Investment Adviser Regulation).

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.\1\
---------------------------------------------------------------------------

    \1\ 17 CFR 200.30-5(e)(2).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.

                                Appendix
------------------------------------------------------------------------

------------------------------------------------------------------------
801-72059.........................  SOLOMON HENDRIX & CO.
801-9488..........................  MAURY WADE & COMPANY.
801-71810.........................  BISHOP ASSET MANAGEMENT, LLC.
801-69144.........................  SAFE HAVEN ADVISORS, INC
801-70781.........................  WANGER OMNIWEALTH, LLC.
801-70401.........................  MIDWEST MORTGAGE ANALYTICS.
801-70533.........................  ALPHAMETRIX, LLC.
801-71189.........................  MORGAN FINCH, LLC.

801-77520.........................  ACCESS STRATEGIC ADVISORY GROUP,
                                     LLC.
801-66662.........................  ARNOTT CAPITAL PTY LTD.
801-71208.........................  KPDN INC.
801-69648.........................  FUTURE VALUE CONSULTANTS LIMITED.
801-65517.........................  FGS CAPITAL LLP.
801-71188.........................  CENTINELA CAPITAL PARTNERS, LLC.
801-72117.........................  MAP ALTERNATIVE ASSET MANAGEMENT
                                     COMPANY, LLC.
801-69898.........................  INSIGHT ONSITE STRATEGIC MANAGEMENT
                                     LLC.
801-10966.........................  GARY EUGENE GIBBONS DBA THE
                                     COLERIDGE GROUP.
801-77747.........................  NEW SOURCE MEDIA ADVISOR, LLC.
801-70916.........................  CMA ADVISORY GROUP, LLC.
801-78409.........................  CASICO, LLC.
801-78848.........................  RCG PARTNERS.
801-72000.........................  STAMBOULI MANAGEMENT CORP.
801-71089.........................  OPTIMIZE CAPITAL.
801-71439.........................  BATTENKILL CAPITAL MANAGEMENT, INC.
801-78049.........................  EXCALIBUR MANAGEMENT, LLC.
801-61973.........................  MEDITRON ASSET MANAGEMENT, LLC.
801-77143.........................  CAMELOT ACQUISITION SECONDARY
                                     OPPORTUNITIES MANAGEMENT, LLC.
801-63963.........................  HARPER ASSOCIATES, LLC.
801-28490.........................  FX CONCEPTS, LLC.
801-76567.........................  CUSTOM FINANCIAL SERVICES, LLC.
801-8984..........................  VALLEY FORGE MANAGEMENT CORP.
801-70460.........................  PAUL-ELLIS INVESTMENT ASSOCIATES.
801-77931.........................  YORKSHIRE CAPITAL MANAGEMENT LLC.
801-77496.........................  WILLIAMS CAPITAL STRATEGIES LLC.
801-72743.........................  NICHOLS CONSULTING.
801-62524.........................  PURCELL ADVISORY SERVICES, LLC.
801-76636.........................  PETROFF INSTITUTIONAL.
801-72299.........................  VASQUEZ & CO.
------------------------------------------------------------------------

[FR Doc. 2015-30838 Filed 12-7-15; 8:45 am]
 BILLING CODE 8011-01-P