[Federal Register Volume 88, Number 125 (Friday, June 30, 2023)]
[Notices]
[Page 42352]
[FR Doc No: 2023-13975]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. TX23-5-000]

THSI bn, LLC; Notice of Filing

    Take notice that on June 21, 2023, pursuant to sections 210 and 212
of the Federal Power Act,\1\ THSI bn, LLC (THSI) filed an application
requesting that the Federal Energy Regulatory Commission (Commission)
require Arizona Electric Power Cooperative (AEPCO) to provide
interconnection service to THSI's proposed Three Sisters Solar Project
(Three Sisters Project or Project), a solar generation and battery
storage project THSI is developing in Cochise, Arizona.
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    \1\ 16 U.S.C. 824i, 824k.
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    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].
    Comment Date: 5:00 p.m. Eastern Time on July 12, 2023.

    Dated: June 26, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-13975 Filed 6-29-23; 8:45 am]
BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 	SUPPORTING STATEMENT

NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS FOR AREA
SOURCES:  	ELECTRIC ARC FURNACE STEELMAKING FACILITIES

PART A

1.0  Identification of the Information Collection

(a) Title and Number of the Information Collection.

	“National Emission Standards for Hazardous Air Pollutants for Area
Sources:  Electric Arc Furnace Steelmaking Facilities.”  This is a new
information collection request (ICR).  The Environmental Protection
Agency (EPA) tracking number for this request is ICR number 2277.02.

(b) Short Characterization.

	Potential respondents are owners or operators of electric arc furnace
(EAF) steelmaking facilities that are area sources of hazardous air
pollutants (HAP) emissions.  The final standards establish particulate
matter (PM) emission limits for control devices and opacity limits for
melt shops; pollution prevention requirements for ferrous scrap that is
melted in EAFs; and monitoring, reporting, and recordkeeping
requirements.

	All respondents are required to comply with the compliance assurance
monitoring requirements in 40 CFR part 64.  Respondents must conduct
initial performance tests (if a performance test has not been conducted
in the previous 5 years) and operate according to a startup, shutdown,
and malfunction plan.  Options are provided for the pollution prevention
requirements for scrap:  (1) restrict the use of certain scrap that
contains contaminants such as mercury, organic liquids, or lead; or (2)
implement a pollution prevention plan for scrap inspection and selection
to limit the amount of organics, mercury, and lead in the scrap.  The
plans must include provisions to demonstrate compliance such as periodic
inspections of incoming scrap and recordkeeping.  All respondents are
required to submit one-time notifications, make semiannual compliance
reports, and maintain records of specific information to ensure that the
rule requirements are being achieved.  These requirements are listed in
Attachment 1.

2.  Need For and Use of the Collection

(a)	Need/Authority for the Collection.

	Section 112(d) of the Clean Air Act (CAA) requires regulation of major
and area sources of HAP that are listed for regulation under section
112(c).  Additional requirements for area sources are described in
section 112(k).  We implement the area source requirements through our
Integrated Urban Air Toxics Strategy (64 FR 38715, July 19, 1999).  The
Integrated Urban Air Toxics Strategy identifies 33 pollutants that pose
the greatest public health concern in the largest number of urban areas
along with the area sources that represent 90 percent of the emissions.
We added EAF steelmaking facilities to the Integrated Urban Air Toxics
Strategy area source category list on June 26, 2002 (67 FR 43112).  Area
source standards established pursuant to the Integrated Urban Air Toxics
Strategy may be based on the maximum achievable control technology
(MACT) under CAA section 112(d)(4) or generally available control
technology (GACT) under CAA section 112(d)(5).  The area source
standards for EAF steelmaking facilities reflect the application of GACT
for emission limits and operating limits.

	Section 112(c)(6) requires EPA to list major and area source categories
that emit any of seven specific pollutants (one of which is mercury).
We must assure that the listed source categories account for 90 percent
of the aggregate emissions of each of the seven specific pollutants and
that the listed source categories are, or will be, subject to MACT
standards under section 112(d).  Since the initial listing (April 10,
2998), we have found that EAF steelmaking facilities are a significant
contributor to mercury emissions.   Concurrent with the proposed rule,
we added EAF steelmaking facilities to the list of source categories
under CAA section 112(c)(6).  The work practice standards for EAF
steelmaking facilities reflect the application of MACT for the control
of mercury emissions.

	Certain records and reports are necessary for the Administrator to:
(1) confirm the compliance status of area sources, identify new or
reconstructed sources subject to the standards; and ensure that the
standards are being achieved on a continuous basis.  These recordkeeping
and reporting requirements are specifically authorized by section 114 of
the CAA (42 U.S.C. 7414) and set out in the General Provisions for
national emission standards for hazardous air pollutants (NESHAP) in 40
CFR Part 63, Subpart A.

(b)	Use/Users of the Data.

	The information will be used by Agency enforcement personnel to ensure
that the rule requirements are being achieved.  Based on review of the
recorded information at the site and the reported information, EPA can
identify facilities that may not be in compliance and decide which
plants, records, or processes should be inspected.

3.	Nonduplication, Consultations, and Other Collection Criteria

(a)	Nonduplication.

	A computer search of the Federal Information Locator System indicated
that, with the exception of the New Source Performance Standards for
Electric Arc Furnaces (40 CFR Part 60, Subparts AA and Aaa), there are
no similar information requests being carried out by the Federal
government.  A similar search of EPA's ongoing ICR's revealed no
duplication of information-gathering efforts.  Most of the requirements
in the final standards have been adopted from the NSPS.  Therefore,
certain reports required by the NSPS or State or local agencies may
duplicate information required by the final standards.  In such cases, a
copy of the report submitted for the NSPS or to the State or local
agency can be provided to the Administrator in lieu of the information
that would be required in the semi-annual compliance report.

(b)  Public Notice Required Prior to ICR Submission to OMB.

	This section is not applicable because this is a rule-related ICR.

(c)	Consultations.

	These final standards were developed in consultation with State and
local agencies, EPA Regional Office experts, individual plants, and
their trade associations.  For example, several meetings and telephone
consultations were held with representatives from the affected plants,
and their trade associations.  The non-EPA persons consulted on the
information collection activities are identified in Table 1.

	TABLE 1.  PERSONS CONSULTED ON THE INFORMATION COLLECTION ACTIVITIES

Contact	Organization	Telephone Number

Eric Stuart	Steel Manufacturers’ Association<PHONE_NUMBER>

Jim Schultz	American Iron and Steel Institute<PHONE_NUMBER>

John Wittenborn	Counsel for the Specialty Steel Industry of North
America<PHONE_NUMBER>

(d)	Effects of Less Frequent Collection.

	If the relevant information were collected less frequently, EPA would
not be reasonably assured that a plant is in compliance with the
standards.

(e)	General Guidelines.

	None of the guidelines in 5 CFR 1320.6 are being exceeded.

(f)	Confidentiality.

	All information submitted to the Agency for which a claim of
confidentiality is made will be safeguarded according to the Agency
policies set forth in Title 40, Chapter 1, Part 2, Subpart B --
Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902,
September 1, 1976; amended by 43 FR 39999, September 28, 1978; 43 FR
42251, September 28, 1978; 44 FR 17674, March 23, 1979).

(g)  Sensitive Questions.

	This section is not applicable because this ICR does not involve
matters of a sensitive nature.

4.	The Respondents and the Information Requested

(a)	Respondents/NAIC Codes.

	Potential respondents are owners or operators of new or existing EAF
steelmaking facilities that are area sources of HAP.  We estimate that
91 plants will be subject to the testing, monitoring, notification,
reporting, and recordkeeping requirements; no new facilities are
expected during the 3-year clearance period of this ICR.  The NAICS
codes for this industry is 331111, “Iron and Steel Mills”.

(b) Information Requested.

	(i) Data Items, Including Recordkeeping Requirements.  Attachment 1,
Source Data and Information Requirements, summarizes the proposed
information collection requirements.	(ii) Respondent Activities.  The
respondent activities required by the proposed amendments are identified
in Table 2 and introduced in section 6(a).

5.	The Information Collected–Agency Activities, Collection
Methodology, and Information Management

(a)	Agency Activities.

	A list of Agency activities is provided in Table 3 and introduced in
section 6(c).

(b)	Collection Methodology and Management.

	This is not relevant to this information collection request.

(c)	Small Entity Flexibility.

	A small entity for this industry is defined by the Small Business
Administration as a firm having no more than 1,000 employees.  Of the 91
facilities that will be subject to the rule, two facilities are
considered to be small entities.

	Although the final rule would not have a significant economic impact on
the small entities, we nonetheless tried to reduce the impact of the
rule on small facilities.  We held several meetings with industry trade
associations and company representatives to discuss the rule and have
included provisions to address their concerns.

(d) Collection Schedule.

	Information contained in the periodic reports submitted to the EPA will
be entered into the Aerometric Information Retrieval System (AIRS)
database which is operated and maintained by EPA’s Office of Air
Quality Planning and Standards.  Information contained in the one-time
only reports will be entered into the National Compliance Data System
operated and maintained by EPA’s Office of Enforcement and Compliance
Assurance.  Data obtained during periodic visits by Agency personnel
from records maintained by the respondents will be tabulated and
published for internal EPA use in enforcement and compliance programs.
A schedule for collection of information and publication of data is not
applicable because reports are triggered by actions of the respondents.

6.  Estimating the Burden and Cost of the Collection

(a)	Estimating Respondent Burden.

	The annual burden estimates for the additional recordkeeping and
reporting requirements in the final rule are shown in Table 2.  These
numbers were derived from estimates based on EPA’s experience with
other standards.

(b)	 Estimating Respondent Costs.

	(i)  Estimating Labor Costs.  Labor rates and associated costs are
based on Bureau of Labor Statistics (BLS) data.  Technical, management,
and clerical average hourly rates for private industry workers were
taken from the United States Department of Labor, Bureau of Labor
Statistics, May 2006, “Occupational Employment Statistics” available
at www.bls.gov.

Wages for occupational groups in NAICS 331100 (Iron and Steel) are used
as the basis for the labor rates with a total compensation of
$32.93/hour for technical (environmental engineer), $45.91/hour for
environmental manager, and $13.76/hour for clerical.  These rates
represent salaries plus fringe benefits and do not include the cost of
overhead.  An overhead rate of 60 percent is used to account for these
costs.  The fully-burdened hourly wage rates used to represent
respondent labor costs are:  technical at $52.69, management at $73.46,
and clerical at $2.02.

	(ii)  Estimating Capital and Operations and Maintenance (O&M) Costs.
As shown in Table 2, no (zero) capital/startup or O&M costs are
associated with the rule over the 3-year period of this ICR.

	(iii) Capital/Startup vs. O&M Costs.  The estimate of capital/startup
costs vs. O&M costs is shown in Table 2.  No (zero) O&M costs are
associated with the rule over the 3-year period of this ICR.

	(iv) Annualizing Capital Costs.  As shown in Table 2, no (zero)
annualized costs are associated with the rule during the 3-year period
of this ICR.

(c)  Estimating Agency Burden and Cost.

	Because the information collection requirements were developed as an
incidental part of standards development, no costs can be attributed to
the development of the information collection requirements.  Because
reporting and recordkeeping requirements on the part of the respondents
are required under the NESHAP General Provisions, no operational costs
will be incurred by the Federal Government.  Publication and
distribution of the information are part of the Compliance Data System,
with the result that no Federal costs can be directly attributed to the
ICR.  Examination of records to be maintained by the respondents will
occur incidentally as part of the periodic inspection of sources that is
part of EPA's overall compliance and enforcement program, and,
therefore, is not attributable to the ICR.  The only costs that the
Federal government will incur are user costs associated with the
analysis of the reported information, as presented in Table 3.

	The Agency labor rates are from the Office of Personnel Management
(OPM) 2007 General Schedule which excludes locality rates of pay.  These
rates are from Salary Table 2007-GS available on the OPM website,
HYPERLINK "https://www.opm.gov/oca/07tables/html/gs_h.asp"
https://www.opm.gov/oca/07tables/html/gs_h.asp .  The government
employee labor rates are $14.16/hour for clerical (GS-6, Step 3), $29.98
for technical (GS-12, Step 1), and $36.36/hr for management (GS-13, Step
5).  These rates were increased by 60 percent to include fringe benefits
and overhead.  The fully-burdened wage rates used to represent Agency
labor costs are:  clerical at $22.66; technical at $43.14, and
management at $58.18.

(d)  Estimating the Respondent Universe and Total Burden and Costs.

	The EPA estimates that 91 area source plants with EAF steelmaking
facilities will be subject to the rule requirements.  No new respondents
are anticipated during the next 3 years.  Therefore, the average annual
number of respondents is 30.3.  Details on the number of respondents
affected by each individual burden item are provided in the footnotes of
Table 2.

	The total number of annual responses for the final rule is 243.  This
number is calculated from the number of respondents subject to one-time
(initial) notification requirements (91) multiplied by the number of
initial reports (2 over 3 years = 0.67 per year), plus the number of
respondents (91) multiplied by the number of semiannual reports (2 per
year).

 (e)	Bottom Line Burden Hours and Cost Tables.

	(i)  Respondent tally.  The bottom line respondent burden hours and
costs, presented in Table 2, are calculated by adding person-hours per
year down each column for technical, managerial, and clerical staff, and
by adding down the cost column.  The average annual burden for the
monitoring, recordkeeping, and reporting requirements in the rule is
2,393 person hours with an annual average cost of $121,573 with no
annual capital and O&M costs.

	(ii)  The Agency tally.  The average annual Federal Government cost for
the existing rule is $8,859 for 192 total annual hours.  The bottom line
Agency burden hours and costs for the final rule, presented in Table 3,
are calculated by adding person-hours per year down each column for
technical, managerial, and clerical staff, and by adding down the cost
column.  In this case, total cost is the sum of this total salary cost
and total travel expenses for tests attended.

	(iii)  Variations in the annual bottom line.   This section does not
apply since no significant variation is anticipated.

(f)	Reasons for Change in Burden.

	This section does not apply because this is a new ICR.

(g)  Burden Statement

	The average annual respondent burden per facility is estimated at 79
hours.  Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.

	An agency may not conduct or sponsor, and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.  The OMB control numbers for EPA's regulations
in 40 CFR part 63 are listed in 40 CFR part 9.

	To comment on the Agency’s need for this information the accuracy of
the provided burden estimates, and any suggestions for minimizing
respondent burden, including through the use of automated collection
techniques, EPA has established a public docket for this ICR under
Docket ID No. OAR-2004-0083, which is available for public viewing at
the Air and Radiation Docket and Information Center in the EPA Docket
Center (EPA/DC), EPA West, Room B-102, 1301 Constitution Ave., NW,
Washington, DC.  The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
 The telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.  An electronic
version of the public docket is available through EPA Dockets (EDOCKET)
at   HYPERLINK  http://www.epa.gov/docket.   Use EDOCKET to submit or
view public comments, and to access the index listing of the contents of
the public docket that are available electronically.  Once in the
system, select “search,”, then key in the docket ID number
identified above.  Also, you can send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA.
Please include the EPA Docket ID No. OAR-2004-0083 in any
correspondence.

PART B

	This section is not applicable because statistical methods are not used
in data collection associated with the proposed standards.

TABLE 2.  ANNUAL RESPONDENT BURDEN AND COST OF REPORTING AND
RECORDKEEPING REQUIREMENTS OF THE PROPOSED STANDARDS

Burden item	(A) Person-hours per occurrence	(B)  No. of occurrences per
respondent	(C) Person-hours per respondent (C=A*B)	(D) Respondents per
yeara	(E) Technical person-hours per year (E=C*D)	(F) Management
person-hours per year

(E*0.05)

	(G) Clerical person-hours per year (E*0.1)	(H) Costb, $

1.  Applications	N/A

	2.  Surveys and Studies	N/A

	3.  Acquisition, Installation, and Utilization of Technology and
Systems 	N/A

	4.  Reporting Requirements

A.  Read instructions	8	1	8	30.3	242	12	24	$14,196

B.  Required activities

Prepare scrap plan and scrap specifications	4	1	4	30.3	121	6.1	12	$7,098

Initial performance testsc

C.  Create information	See 4B

	D.  Gather existing information	See 4B

	E.  Write report	See 4B

	Initial notification of applicability	2	1	2	30.3	61	3.0	6.1	$3,549

Notification of compliance status	2	1	2	30.3	61	3.0	6.1	$3,549

Request for compliance extension	N/A

	Notification of performance testc

Startup, shutdown, and malfunction plan/reports	4	1	4	30.3	121	6.1	12
$7,098

 Semiannual excess emissions reports	2	2	4	91	364	18.2	36	$21,317

5.  Recordkeeping Requirements

A.  Read instructions	See 4A

	B.  Plan activities	See 4A

	C.  Implement activities	See 4A

	D   Develop record system 	4	1	4	30.3	121	6.1	12	$7,098

E.  Time to enter information 	0.5	52	26	30.3	788	39	79	$46,135

F.  Time to transmit or disclose information	0.25	2	1	30.3	15	0.8	1.5
$887

G.  Time to adjust existing ways	2	1	2	30.3	61	3.0	6.1	$3,549

F.  Time to train personnel	4	1	4	30.3	121	6.1	12	$7,098

G.  Time for audits	N/A

	TOTAL LABOR BURDEN AND COST

	2,393 hrs	$121,573

     Annualized cost of capitald

$0

     Operation and maintenance (O&M)d

$0

     Total (capital recovery plus O&M)d

$0

N/A = not applicable.

a  There are 91 EAF steelmaking facilities.  The average number of
respondents per year for one time events over the 3-year period of the
ICR is 30.3 (91÷3=30.3).

b This ICR uses the following labor rates: $73.46 for managerial labor,
$52.69 for technical labor, and $22.02 for clerical labor.  These rates
are from the U.S. Department of Labor, Bureau of Labor Statistics, May
2006, for NAICS 331100 (Iron and Steel).  The rates have been increased
by 60% to account for overhead.

c  All plants have conducted performance tests within the previous 5
years.  No additional performance tests are attributed to the proposed
rule.

d  All plants already have installed monitoring equipment as a result of
the compliance assurance monitoring rule (40 CFR part 64) and their
title V permit requirements.  The proposed rule will not require any
additional monitoring equipment.	TABLE 3.  ANNUAL BURDEN AND COST TO
THE FEDERAL/STATE GOVERNMENT OF THE PROPOSED STANDARDS

Burden Item	(A) Person hours per occurrence	(B) Occurrences per
respondent	(C) Plants per yeara	(D) Technical hours/year (D=A*B*C)	(E)
Management   hours/year (E=0.05*D)	(F) Clerical-hours/year (F=0.1*D)
(G) Costb, $

Report Review:

  Initial notification of applicability 	1	1	30.3	30.3	1.5	3.0	$1,610

  Startup, shutdown, malfunction plan/report	2	1	30.3	60.6	3.0	6.1
$3,220

  Notification of compliance status	1	1	30.3	30.3	1.5	3.0	$1,610

  Semiannual excess emissions report	0.5	1	91	46	2.3	4.6	$2,418

TOTAL BURDEN AND COST	 	 	 	192	$8,859

a  There are 91 EAF steelmaking facilities.  The average number of
respondents per year for one time events over the 3-year period of the
ICR is 30.3 (91÷3=30.3).

b This ICR uses the following average hourly labor rates: 58.18 for
managerial (GS-13, Step 5, $36.36 x 1.6), $43.14 (GS-12, Step 1, $29.98
x 1.6) for technical and $22.66 (GS-6, Step 3, $14.16 x 1.6) for
clerical.  These rates are from the Office of Personnel Management (OPM)
“2007 General Schedule” which excludes locality rates of pay.

ATTACHMENT  1.  SOURCE DATA AND INFORMATION REQUIREMENTS

Requirement	Regulation  citation	General Provisions

 citation	Record retention

STUDIES AND PLANS

Scrap management plan	63.10685(a)(1) and (b)(1)

Kept onsite at all times

Startup, shutdown, and malfunction plan

63.6(e)(3)	Kept onsite at all times

REPORTS

Notification of applicability

63.9(b)(1)	5 years

Notification of construction/reconstruction

63.9(b)(4)	5 years

Compliance extension

63.9(c)	5 years

Notification of special requirements

63.9(d)	5 years

Notification of performance test

63.9(e)	5 years

Notification of opacity observations

63.9(f)	5 years

Additional COMS notifications

63.9(g)	5 years

Notification of compliance status	63.10690(b)	63.9(h)	5 years

Semiannual compliance report	63.10685(c)	 	5 years

Startup, shutdown,  malfunction report

63.10(d)(5)(ii)	5 years

RECORDKEEPING

Notifications and reports

63.10(b)(2)(xiv)	5 years

Startups, shutdowns, malfunctions

63.6(e)(1)(iii)-(v)	5 years

Performance tests, performance evaluations, and opacity observations

63.10(b)(2)(viii)-(ix)	5 years

Emission/operating limits

63.10(b)(2)(vii)	5 years

Scrap management requirements	63.10685(c)	63.10(b)(2)(iii)	5 years

Continuous monitoring systems

63.10(b)(2)(vi)- (vii), (x)-(xi) 63.10(c) ; 63.6(h)(7); 63.8(d)(3)	5
years


[Federal Register Volume 81, Number 178 (Wednesday, September 14, 2016)]
[Notices]
[Page 63178]
[FR Doc No: 2016-22040]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG16-145-000.
    Applicants: Cimarron Bend Wind Project II, LLC.
    Description: Self-Certification of EG or FC of Cimarron Bend Wind
Project II, LLC.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5366.
    Comments Due: 5 p.m. ET 9/27/16.

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

    Docket Numbers: ER16-1912-001.
    Applicants: Southwest Power Pool, Inc.
    Description: Tariff Amendment: Deficiency Response in ER16-1912--
Out-of-Merit Energy Clarification to be effective 7/1/2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5419.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2285-001.
    Applicants: Desert Wind Farm LLC.
    Description: Tariff Amendment: Amendment to 1 to be effective 9/24/
2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5298.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2462-001.
    Applicants: Oregon Clean Energy, LLC.
    Description: Tariff Amendment: Amendment to Application for MBR to
be effective 10/21/2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5299.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2552-000.
    Applicants: Municipal Energy of PA, LLC.
    Description: Notice of Cancellation of Market-Based Rate Tariff of
Municipal Energy of PA, LLC.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5316.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2553-000.
    Applicants: Avista Corporation.
    Description: Sec.  205(d) Rate Filing: Avista Corp FERC Rate
Schedule No. 184 extension to be effective 10/1/2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5296.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2554-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2016-09-06_Order 809 True-up
filing to be effective 11/5/2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5297.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2555-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Queue Position X2-012/AA2-
008, Service Agreement No. 3569 to be effective 8/4/2016.
    Filed Date: 9/6/16.
    Accession Number: 20160906-5369.
    Comments Due: 5 p.m. ET 9/27/16.

    Docket Numbers: ER16-2556-000.
    Applicants: Hinson Power Company, LLC.
    Description: Tariff Cancellation: Cancellation (Complete Tariff ID)
to be effective 9/7/2016.
    Filed Date: 9/7/16.
    Accession Number: 20160907-5015.
    Comments Due: 5 p.m. ET 9/28/16.

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

    Dated: September 7, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-22040 Filed 9-13-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 135 (Friday, July 13, 2018)]
[Notices]
[Page 32660]
[FR Doc No: 2018-14979]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-515-000]

Notice of Request Under Blanket Authorization: Columbia Gas
Transmission, LLC

    Take notice that on June 29, 2018, Columbia Gas Transmission, LLC
(Columbia), 700 Louisiana Street, Houston, Texas 77002-2700, filed a
prior notice request pursuant to Sections 157.205 and 157.216 of the
Commission's regulations, for authorization to abandon two injection/
withdrawal (I/W) wells at its Brinker Storage Field, located in
Columbiana County, Ohio, one I/W well at its Victory B Storage Field,
located in Marshall County, West Virginia, and associated pipelines and
appurtenances. Columbia proposes to abandon these facilities under
authorities granted by its blanket certificate issued in Docket No.
CP83-76, all as more fully set forth in the application which is on
file with the Commission and open to public inspection. The filing may
also be viewed on the web at http://www.ferc.gov using the eLibrary
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at [email protected] or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Linda Farquhar, Manager, Project Determinations & Regulatory
Administration, Columbia Gas Transmission, LLC, 700 Louisiana Street,
Suite 700, Houston, Texas, 77002-2700, at<PHONE_NUMBER> or fax (832)
320-6685 or [email protected].
    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be
treated as an application for authorization pursuant to section 7 of
the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
website (www.ferc.gov) under the e-Filing link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy regulatory Commission, 888 First
Street NE, Washington, DC 20426.

    Dated: July 9, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-14979 Filed 7-12-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: June 9, 2006 (Volume 71, Number 111)]
[Proposed Rules]
[Page 33413-33416]
[DOCID:fr09jn06-8]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0464; FRL-8182-1]

Revisions to the Nevada State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve revisions to the Nevada State
Implementation Plan (SIP). These revisions concern the Air Pollution
sections of the Nevada Revised Statutes (NRS). We are proposing to
approve the

submitted statutes in order to bring the Nevada SIP up to date. These
statutes are being approved under the Clean Air Act as amended in 1990
(CAA or the Act). We are taking comments on this proposal and plan to
follow with a final action.

DATES: Any comments must arrive by July 10, 2006.

ADDRESSES: Submit comments, identified by docket number EPA-R09-OAR-
2006-0464, by one of the following methods:
    1. Federal eRulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions.
    2. E-mail<EMAIL_ADDRESS>    3. Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental
Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA
94105-3901.
    Instructions: All comments will be included in the public docket
without change and may be made available online at http://www.regulations.gov
, including any personal information provided,

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

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

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

FOR FURTHER INFORMATION CONTACT: Julie Rose, EPA Region IX, (415) 947-
4126<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. The State's Submittal
    A. What statutes did the state submit for approval?
    B. What is the regulatory history of the Nevada SIP?
    C. What is the purpose of this proposed rule?
II. EPA's Evaluation and Action
    A. How is EPA evaluating the statutes submitted for approval?
    B. Do the statutes meet the evaluation criteria?
    C. Public comment and final action.
III. Statutory and Executive Order Reviews

I. The State's Submittal

A. What statutes did the state submit for approval?

    The Governor's designee, the Nevada Department of Conservation and
Natural Resources, Division of Environmental Protection (NDEP),
submitted a large revision to the applicable SIP on January 12, 2006.
On March 23, 2006, the Nevada SIP submittal dated January 12, 2006 was
found to meet the completeness criteria in 40 CFR part 51 Appendix V,
which must be met before formal EPA review. On March 24, 2006, the NDEP
submitted an additional revision consisting of a definition found in
Title 0, Preliminary Chapter of the General Provisions of the NRS. On
May 17, 2006, the submittal dated March 24, 2006 was found to meet the
completeness criteria in 40 CFR part 51 Appendix V. The primary purpose
of these revisions is to clarify and harmonize State and federally
enforceable requirements. Because these revisions incorporate so many
changes from the 1970s and 1980s vintage SIP regulations, EPA has
decided to review and act on the submittal in a series of separate
actions. The first such action was finalized in the Federal Register on
March 27, 2006, (71 FR 15040). The remaining portions of the submittal
will be acted on in future Federal Register actions.
    The following table lists the Nevada Revised Statutes (NRS)
addressed by this proposal with the dates they were submitted by NDEP.

                     Statutes Submitted for Approval
------------------------------------------------------------------------
                                                              Submittal
 Nevada revised  statutes  (NRS)            Title                date
------------------------------------------------------------------------
445B.105........................  Definitions..............     01/12/06
445B.110........................  Air contaminant..........     01/12/06
445B.115........................  Air pollution............     01/12/06
445B.120........................  Commission...............     01/12/06
445B.125........................  Department...............     01/12/06
445B.130........................  Director.................     01/12/06
445B.135........................  Federal Act..............     01/12/06
445B.140........................  Hazardous air pollutant..     01/12/06
445B.145........................  Operating permit.........     01/12/06
445B.150........................  Person...................     01/12/06
0.039...........................  Person...................     03/24/06
445B.155........................  Source and indirect           01/12/06
                                   source.
445B.210........................  Powers of Commission.....     01/12/06
445B.220........................  Additional powers of          01/12/06
                                   Commission.
445B.225........................  Power of Commission to        01/12/06
                                   require testing of
                                   sources.
445B.235........................  Additional powers of the      01/12/06
                                   Department.
445B.245........................  Power of Department to        01/12/06
                                   perform or require test
                                   of emissions from stacks.
445B.275........................  Creation; members; terms.     01/12/06
445B.280........................  Attendance of witnesses       01/12/06
                                   at hearing; contempt;
                                   compensation.
445B.300........................  Operating permit for          01/12/06
                                   source of air
                                   contaminant; notice and
                                   approval of proposed
                                   construction;
                                   administrative fees;
                                   failure of Commission or
                                   Department to act.
445B.320........................  Approval of plans and         01/12/06
                                   specifications required
                                   before construction or
                                   alteration of structure.

445B.500........................  Establishment and             01/12/06
                                   administration of
                                   program; contents of
                                   program; designation of
                                   air pollution control
                                   agency of county for
                                   purposes of federal act;
                                   powers and duties of
                                   local air pollution
                                   control board; notice of
                                   public hearings;
                                   delegation of authority
                                   to determine violations
                                   and levy administrative
                                   penalties; cities and
                                   smaller counties;
                                   regulation of certain
                                   electric plants
                                   prohibited.
445B.510........................  Commission may require        01/12/06
                                   program for designated
                                   area.
445B.520........................  Commission may establish      01/12/06
                                   or supersede county
                                   program.
445B.530........................  Commission may assume         01/12/06
                                   jurisdiction over
                                   specific classes of air
                                   contaminants.
445B.540........................  Restoration of superseded     01/12/06
                                   local program;
                                   continuation of existing
                                   local program.
445B.560........................  Plan or procedure for         01/12/06
                                   emergency.
445B.595........................  Governmental sources of       01/12/06
                                   air contaminants to
                                   comply with state and
                                   local provisions
                                   regarding air pollution;
                                   permit to set fire for
                                   training purposes;
                                   planning and zoning
                                   agencies to consider
                                   effects on quality of
                                   air.
------------------------------------------------------------------------

B. What is the regulatory history of the Nevada SIP?

    Pursuant to the Clean Air Amendments of 1970, the Governor of
Nevada submitted the original SIP to EPA in January 1972. EPA approved
certain portions of the original SIP and disapproved others under CAA
section 110(a). See 37 FR 10842 (May 31, 1972). For some of the
disapproved portions, EPA promulgated substitute provisions, referred
to as Federal implementation plan (FIP) provisions, under CAA section
110(c).
    The original SIP included various rules, codified as articles
within the Nevada Air Quality Regulations (NAQR), and various statutory
provisions codified in title 40, chapter 445 of the Nevada Revised
Statutes (NRS). In the early 1980's, Nevada reorganized and re-codified
its air quality rules as sections within chapter 445 of the Nevada
Administrative Code (NAC). Today, Nevada codifies its air quality
regulations in chapter 445B of the NAC and codifies air quality
statutes in chapter 445B of title 40 of the NRS.
    Nevada adopted and submitted many revisions to the original set of
regulations and statutes in the SIP, some of which EPA approved on
February 6, 1975 at 40 FR 5511; on March 26, 1975 at 40 FR 13306; on
January 9, 1978 at 43 FR 1341; on January 24, 1978 at 43 FR 3278; on
August 21, 1978 at 43 FR 36932; on July 10, 1980 at 45 FR 46384; on
April 14, 1981 at 46 FR 21758; on August 27, 1981 at 46 FR 43141; on
March 3, 1982 at 47 FR 9833; on April 13, 1982 at 47 FR 15790; on June
18, 1982 at 47 FR 26386; on June 23, 1982 at 47 FR 27070; on March 27,
1984 at 49 FR 11626. Since 1984, EPA has approved very few revisions to
Nevada's applicable SIP despite numerous changes that have been adopted
locally. As a result, the version of the rules enforceable by NDEP is
often quite different from the SIP version enforceable by EPA.

C. What is the purpose of this proposed rule?

    The purpose of this proposal is to bring the applicable SIP up to
date. We are proposing to approve the statutes contained in Nevada's
January 12, 2006 and March 24, 2006 submittals.

II. EPA's Evaluation and Action

A. How is EPA evaluating the statutes submitted for approval?

    We have reviewed the statutes submitted by NDEP on January 12, 2006
and March 24, 2006 for compliance with the CAA requirements for SIPs in
general set forth in CAA section 110(a)(2) and 40 CFR part 51 and also
for compliance with CAA requirements for SIP revisions in CAA section
110(l) and 193.

B. Do the statutes meet the evaluation criteria?

    We believe the NRS statutes listed in the table are consistent with
the relevant policy and guidance regarding enforceability and SIP
relaxations. The TSD has more information on our evaluation.

C. Public Comment and Final Action

    Because EPA believes the Nevada SIP will continue to fulfill all
relevant requirements, we are proposing to fully approve the submitted
revisions in accordance with section 110(k)(3) of the Act. We will
accept comments from the public on this proposal for the next 30 days.
Unless we receive convincing new information during the comment period,
we intend to publish a final approval action that will approve these
statutes into the federally enforceable SIP.

III. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a ``significant regulatory action'' and
therefore is not subject to review by the Office of Management and
Budget. For this reason, this action is also not subject to Executive
Order 13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This
proposed action merely proposes to approve state law as meeting Federal
requirements and imposes no additional requirements beyond those
imposed by state law. Accordingly, the Administrator certifies that
this proposed rule will not have a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.). Because this rule proposes to approve pre-
existing requirements under state law and does not impose any
additional enforceable duty beyond that required by state law, it does
not contain any unfunded mandate or significantly or uniquely affect
small governments, as described in the Unfunded Mandates Reform Act of
1995 (Pub. L. 104-4).
    This proposed rule also does not have tribal implications because
it will not have a substantial direct effect on one or more Indian
tribes, on the relationship between the Federal Government and Indian
tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian tribes, as specified by Executive
Order 13175 (65 FR 67249, November 9, 2000). This action also does not
have Federalism implications because it does not have substantial
direct effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various

levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999). This action merely proposes to approve a state
rule implementing a Federal standard, and does not alter the
relationship or the distribution of power and responsibilities
established in the Clean Air Act. This proposed rule also is not
subject to Executive Order 13045 ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), because it is not economically significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This proposed rule does
not impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Authority: 42 U.S.C. 7401 et seq.

    Dated: May 25, 2006.
Laura Yoshii,
Acting Regional Administrator, Region IX.
[FR Doc. E6-9000 Filed 6-8-06; 8:45 am]

BILLING CODE 6560-50-P


From: John Whitaker<EMAIL_ADDRESS>Sent: Friday, August 09, 2002 11:08 AM
To: John B. Sunda (E-mail)
Cc: John Brandt
Subject: EPA 316b Rule Questions

John,

Here is the rest of the information you requested.  If I can be of further
help, please feel free to call.  Thanks again for the list of potential
customers.

Regards,
John Whitaker
Engineering
270-685-5138

 <<EPA 316b SURVEY.xls>>


[Federal Register Volume 86, Number 169 (Friday, September 3, 2021)]
[Notices]
[Pages 49543-49546]
[FR Doc No: 2021-19116]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1857]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food, and Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Food for
Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by October 4, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0751. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice and Hazard Analysis, and Risk-Based
Preventive Controls for Human Food--21 CFR Part 117; Current Good
Manufacturing Practice and Hazard Analysis, and Risk-Based Preventive
Controls for Food for Animals--21 CFR Part 507

OMB Control Number 0910-0751--Revision

    This information collection supports FDA regulations setting forth
criteria and definitions applicable to human food and to animal food,
as established under the FDA Food Safety and Modernization Act (FSMA)
(Pub. L. 111-353). Congress enacted FSMA in response to dramatic
changes in the global food system and in our understanding of foodborne
illness and its consequences, including the realization that
preventable foodborne illness is both a significant public health
problem and a threat to the economic well-being of the food system. The
purpose of the regulations is to prevent the introduction of
adulterated and/or misbranded products into the marketplace and ensure
the safety of both human foods and animal food in accordance with
sections 402 and 403 of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 342 and 343). Generally, domestic and foreign food
facilities that are required to register in accordance with section 415
of the FD&C Act (21 U.S.C. 350d) must comply with these requirements,
unless an exemption applies. It is important to note, however, that
applicability of the current good manufacturing practice requirements
for animal food is dependent upon whether a facility is required to
register, while the applicability of the current good manufacturing
practice requirements for human food is not dependent upon whether a
facility is required to register. Regulations governing human food are
set forth in part 117 (21 CFR part 117), while regulations governing
animal food are found in part 507 (21 CFR part 507). Respondents to the
information collection are those who manufacture, prepare, pack, or
hold food intended for humans or animals.
    The regulations include recordkeeping necessary to demonstrate
compliance with the requirements; however, respondents that meet the
definition of a ``qualified facility,'' under 21 CFR 117.3 and 507.3,
are subject to reporting. To be subject to the modified requirements
set forth in part 117, subpart D and part 507, subpart A for human food
and animal food, respectively, respondents must attest to their status.
To assist respondents in this regard, we have developed Forms FDA 3942a
(Quality Facility Attestation: Human Food) and 3942b (Quality Facility
Attestation: Animal Food), available for downloading from our website
at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/qualified-facility-attestation.
    Section 418(l)(2)(B)(ii) of the FD&C Act (21 U.S.C.
350g(l)(2)(B)(ii)) directs us to issue guidance on documentation
required to determine status as a qualified facility. Accordingly, we
issued a guidance for industry entitled ``Determination of Status as a
Qualified Facility Under part 117: Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Human Food and
part 507: Current Good Manufacturing Practice, Hazard Analysis, and
Risk-Based Preventive Controls for Food for Animals,'' also available
for downloading from our website at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-determination-status-qualified-facility. The guidance discusses the
content, format, frequency, and timing of submissions. For efficiency
of Agency operations, we are now accounting for burden we attribute to
reporting associated with Forms FDA 3942a and 3942b, currently approved
under OMB control number 0910-0854, with this information collection.
    In the Federal Register of March 16, 2021 (86 FR 14436), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
          21 CFR section; reporting                Number of        responses per       Total annual       Average burden per response      Total hours
                                                  respondents         respondent         responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(c); qualified facility as reported on             37,134            \2\ 0.5             18,567  0.5 (30 minutes)................           9,284
 Form FDA 3942a.
507.7(c); qualified facility as reported on                1,120                0.5                560  0.5 (30 minutes)................             280
 Form FDA 3942b.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  .................  .................  .................  ................................           9,564
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Reporting occurs biennially.

                                             Table 2--Estimated Annual Recordkeeping Burden: Human Foods \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of      Number of records     Total annual
           21 CFR section; activity              recordkeepers     per recordkeeper       records       Average burden per recordkeeping    Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.126(c) and 117.170(d); food safety plan               46,685                  1             46,685  110.............................       5,135,350
 and reanalysis.
117.136; assurance records...................             16,285                  1             16,285  0.25 (15 minutes)...............           4,071
117.145(c); monitoring records...............              8,143                730          5,944,390  0.05 (3 minutes)................         297,220

117.150(d); corrective actions and                        16,285                  2             32,570  1...............................          32,570
 corrections records.
117.155(b); verification records.............              8,143                244          1,986,892  0.05 (3 minutes)................          99,345
117.160; validation records..................              3,677                  6             22,062  0.25 (15 minutes)...............           5,515
117.475(c)(7)-(9); supplier records..........             16,285                 10            162,850  4...............................         651,400
117.180(d); training records for preventive               46,685                  1             46,685  0.25 (15 minutes)...............          11,671
 controls qualified individual.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  .................  .................  .................  ................................       6,237,142
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                             Table 3--Estimated Annual Recordkeeping Burden: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Number of      Number of records     Total annual                                        Total hours
           21 CFR section; activity              recordkeepers     per recordkeeper       records       Average burden per recordkeeping        \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Subpart A--General Provisions
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.4(d); documentation of animal food safety              7,469               0.75              5,579  0.05 (3 minutes)................             279
 and hygiene training.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                              Subpart C--Hazard Analysis and Risk-Based Preventive Controls
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.31 through 507.55; food safety plan--                  7,469                519          3,876,411  0.1 (6 minutes).................         387,641
 including hazard analysis, preventive
 controls, and procedures for monitoring,
 corrective actions, verification, recall
 plan, validation, reanalysis, modifications,
 and implementation records.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Subpart E--Supply Chain Program
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.105 through 507.175; written supply-chain              7,469                519          3,876,411  0.1 (6 minutes).................         387,641
 program--including records documenting
 program.
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Subpart F--Requirements Applying to Records That Must Be Established and Maintained
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.200 through 507.215; general                           7,469                519          3,876,411  0.1 (6 minutes).................         387,641
 requirements, additional requirements
 applying to food safety plan, requirements
 for record retention, use of existing
 records, and special requirements applicable
 to written assurance.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  .................  .................         11,635,372  ................................       1,163,258
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Total hours have been rounded.

                                        Table 4--Estimated Annual Third-Party Disclosure Burden: Human Foods \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
          21 CFR section; activity                Number of        disclosures per      Total annual      Average burden per disclosure    Total hours
                                                 respondents         respondent          disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
117.201(e); disclosure of food                          37,134                   1              37,134   0.25 (15 minutes).............           9,284
 manufacturing facility address.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                        Table 5--Estimated Annual Third-Party Disclosure Burden: Animal Food \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
           21 CFR section; activity                Number of       disclosures per      Total annual      Average burden per disclosure     Total hours
                                                  respondents         respondent        disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
507.27(b); labeling for the animal food                      330                 10              3,300  0.25 (15 minutes)...............             825
 product contains the specific information
 and instructions needed so the food can be
 safely used for the intended animal species.
507.7(e)(1); change labels on products with                1,120                  4              4,480  1...............................           4,480
 labels.
507.7(e)(2); change address on labeling                      974                  1                974  1...............................             974
 (sales documents) for qualified facilities.
507.25(a)(2); animal food, including raw                     373                312            116,376  0.01 (36 seconds)...............        1,163.76
 materials, other ingredients, and rework, is
 accurately identified.
507.28(b); holding and distribution of human              40,798                  2             81,596  0.25 (15 minutes)...............          20,399
 food byproducts for use as animal food.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  .................  .................  .................  ................................       27,841.76
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made slight adjustments to reflect a
decrease in third-party disclosure burden associated with animal food.
In this submission we provide a cumulative estimate for related
disclosure activities that we had previously accounted for separately.

    Dated: August 31, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19116 Filed 9-2-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Page 15212]
[FR Doc No: 2019-07371]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

Filings Instituting Proceedings

    Docket Number: PR19-54-000.
    Applicants: Impulsora Pipeline, LLC.
    Description: Tariff filing per 284.123(b),(e)/: Baseline SOC to be
effective 3/5/2019.
    Filed Date: 4/4/19.
    Accession Number:<PHONE_NUMBER>37.
    Comments/Protests Due: 5 p.m. ET 4/25/19.

    Docket Number: PR19-55-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH Rates effective
April 1 2019 to be effective 4/1/2019.
    Filed Date: 4/4/19.
    Accession Number:<PHONE_NUMBER>41.
    Comments/Protests Due: 5 p.m. ET 4/25/19.

    Docket Numbers: RP19-1059-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Tariff Amendment: Amendment to RP19-1059-000 to be
effective 4/1/2019.
    Filed Date: 4/3/19.
    Accession Number: 20190403-5024.
    Comments Due: 5 p.m. ET 4/15/19.

    Docket Numbers: RP19-992-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Tariff Amendment: Amendment to RP19-992-000 to be
effective 4/1/2019.
    Filed Date: 4/3/19.
    Accession Number: 20190403-5025.
    Comments Due: 5 p.m. ET 4/15/19.

    Docket Numbers: RP19-1069-001.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Tariff Amendment: Amendment to Docket No. RP19-1069-
000 to be effective 4/1/2019.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5012.
    Comments Due: 5 p.m. ET 4/16/19.

    Docket Numbers: RP19-1108-000.
    Applicants: Wyckoff Gas Storage Company, LLC.
    Description: Compliance filing Order 587-Y Compliance to be
effective 8/1/2019.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5062.
    Comments Due: 5 p.m. ET 4/16/19.

    Docket Numbers: RP19-1110-000.
    Applicants: Tres Palacios Gas Storage LLC.
    Description: Sec.  4(d) Rate Filing: Tres Palacios Gas Storage
LLC--Filing of Tariff Modifications to be effective 5/5/2019.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5077.
    Comments Due: 5 p.m. ET 4/16/19.

    Docket Numbers: RP19-1111-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Spire MS SP347466 to be
effective 4/4/2019.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5210.
    Comments Due: 5 p.m. ET 4/16/19.

    Docket Numbers: RP19-351-002.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Compliance filing 2019 Settlement RP19-351 to be
effective 11/1/2019.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5165.
    Comments Due: 5 p.m. ET 4/16/19.

    Docket Numbers: RP19-414-001.
    Applicants: Northern Border Pipeline Company.
    Description: Compliance filing Northern Border Amended Settlement
Filing.
    Filed Date: 4/4/19.
    Accession Number: 20190404-5104.
    Comments Due: 5 p.m. ET 4/16/19.

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

    Dated: April 8, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-07371 Filed 4-12-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Pages 58619-58621]
[FR Doc No: 2017-26794]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6455]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance on Consultation Procedures: Foods Derived
From New Plant Varieties

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's consultation procedures for foods derived from new plant
varieties, including the information collection provisions in the
guidance entitled, ``Guidance on Consultation Procedures: Foods Derived
From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final
Consultation For Food Derived From a New Plant Variety (Biotechnology
Final Consultation),'' which developers may use to prepare the final
consultation in a standard format.

DATES: Submit either electronic or written comments on the collection
of information by February 12, 2018.

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 February 12, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 12, 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 No.
FDA-2017-N-6455 for ``Guidance on Consultation Procedures: Foods
Derived from New Plant Varieties.'' 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 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: Ila Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Guidance on Consultation Procedures: Foods Derived From New Plant
Varieties

OMB Control Number 0910-0704--Extension

    This information collection supports the above captioned Agency
guidance document. FDA recommends that producers who use biotechnology
in the manufacture or development of foods and food ingredients work
cooperatively with FDA to ensure that products derived through
biotechnology are safe and comply with all applicable legal
requirements and has instituted a voluntary consultation process with
industry. To facilitate this process, the Agency has issued a guidance
entitled, ``Guidance on Consultation Procedures: Foods Derived From New
Plant Varieties,'' which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation
process for the evaluation of information on new plant varieties
provided by developers. The Agency believes this consultation process
will help ensure that human food and animal feed safety issues or other
regulatory issues (e.g. labeling) are resolved prior to commercial
distribution. Additionally, such communication will help to ensure that
any potential food safety issues regarding a new plant variety are
resolved during development, and will help to ensure that all market
entry decisions by the industry are made consistently and in full
compliance with the standards of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
    Since 1992, when FDA issued its ``Statement of Policy: Foods
Derived From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May
29, 1992), FDA has encouraged developers of new plant varieties,
including those varieties that are developed through biotechnology, to
consult with FDA during the plant development process to discuss
possible scientific and regulatory issues that might arise. In the 1992
policy, FDA explained that, under the FD&C Act, developers of new foods
(in this document food refers to both human food and animal feed) have
a responsibility to ensure that the foods they offer to consumers are
safe and in compliance with all requirements of the FD&C Act (57 FR
22984 at 22985).
    Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.

    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of                          Average
                Activity                           FDA Form No.               No. of      responses  per   Total annual     burden per      Total hours
                                                                            respondents      respondent      responses       response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation....................  None..........................              20               2              40               4             160
Final consultation......................  3665..........................              12               1              12             150           1,800
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ..............................  ..............  ..............  ..............  ..............           1,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We have retained the currently approved burden estimate for this
information collection and discuss the information collection
activities below.
Initial Consultations
    Initial consultations are generally a one-time burden, although a
developer might return more than once to discuss additional issues
before submitting a final consultation. As noted in the guidance, FDA
encourages developers to consult early in the development phase of
their products, and as often as necessary. Historically, firms
developing a new bioengineered plant variety intended for food use have
generally initiated consultation with FDA early in the process of
developing such a variety, even though there is no legal obligation for
such consultation. These consultations have served to make FDA aware of
foods and food ingredients before these products are distributed
commercially, and have provided FDA with the information necessary to
address any potential questions regarding the safety, labeling, or
regulatory status of the food or food ingredient. As such, these
consultations have provided assistance to both industry and the Agency
in exercising their mutual responsibilities under the FD&C Act.
    FDA estimates that its Center for Veterinary Medicine and its
Center for Food Safety and Applied Nutrition jointly received an
average of 40 initial consultations per year in the last 3 years via
telephone, email, or written letter. Based on this information, we
expect to receive no more than 40 annually in the next 3 years.
Final Consultations
    Final consultations are a one-time burden. At some stage in the
process of research and development, a developer will have accumulated
the information that the developer believes is adequate to ensure that
food derived from the new plant variety is safe and that it
demonstrates compliance with the relevant provisions of the FD&C Act.
The developer will then be in a position to conclude any ongoing
consultation with FDA. The developer submits to FDA a summary of the
safety and nutritional assessment that has been conducted about the
bioengineered food that is intended to be introduced into commercial
distribution. FDA evaluates the submission to ensure that all potential
safety and regulatory questions have been addressed. FDA has developed
a form that prompts a developer to include certain elements in the
final consultation in a standard format: Form FDA 3665 entitled,
``Final Consultation for Food Derived From a New Plant Variety
(Biotechnology Final Consultation).'' The form, and elements that would
be prepared as attachments to the form, can be submitted in electronic
format.
    We base our estimate of the average time to prepare a submission on
informal contact with firms that made one or more biotechnology
consultation submission under the voluntary biotechnology consultation
process. As such, we estimate the average time to prepare a submission
for final consultation to be 150 hours.

    Dated: December 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26794 Filed 12-12-17; 8:45 am]
 BILLING CODE 4164-01-P