environment, market participants are free to choose which competing
exchange or reseller to use to satisfy their business needs. As a
result, the Exchange believes this proposed rule change permits fair
competition

among national securities exchanges. Accordingly, the Exchange does not
believe its proposed fee change imposes any burden on competition that
is not necessary or appropriate in furtherance of the purposes of the
Act.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \82\ and paragraph (f) of Rule 19b-4 \83\
thereunder. At any time within 60 days of the filing of the proposed
rule change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission will institute proceedings to
determine whether the proposed rule change should be approved or
disapproved.
---------------------------------------------------------------------------

    \82\ 15 U.S.C. 78s(b)(3)(A).
    \83\ 17 CFR 240.19b-4(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-CBOE-2019-111 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2019-111. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CBOE-2019-111, and should be submitted
on or before January 8, 2020.
---------------------------------------------------------------------------

    \84\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\84\
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2019-27194 Filed 12-17-19; 8:45 am]
 BILLING CODE 8011-01-P


316B RULE

 TELEPHONE LOG

Name of Caller: 	John Sunda, SAIC

Date: 	August 25, 2009

Company Name: 	ProChemTech International Inc.

Street Address:

City/State/ZIP:	Pennsylvania

Person Contacted:	Timothy Keister

Title:	Certified Water Technologist

Telephone #<PHONE_NUMBER>

Called to inquire about technical, treatment chemical usage and cost
issues regarding the impact of increasing cycles of concentration (COC)
in cooling towers.

Contacted Mr Keister after reading his paper “Cooling Water Management
Basic Principles and Technology.”

He said they don’t have many power plants as clients but have worked
with plants up to 2000 MW. A recent client is a 90 MW plant Scrubgrass
Generating plant in Pennsylvania.

He said that most power plant use very rudimentary treatment chemical
systems for their cooling towers such as using biocides only. For
example they may only use chlorination and some still use chlorine gas.

  In general as you increase the cycles of concentration the biocides
costs will not vary that much but you will need to start using an
antiscale treatment chemical like phosphonate and a solids dispersant
like polyacrylate. If they are already treating makeup water for
corrosion, scale, or solids increasing COC may actually reduce treatment
chemical costs.  They have found that the optimal COC with respect to
chemical costs is in the range of 3 to 6.  Also you may want to treat
with acid to reduce pH. Although his paper does not recommend using acid
this is mostly advice for smaller HVAC and industrial systems.

For a typical system operating around 3 to 6 cycles of concentration,
the following dosage would be appropriate:

Phosphonate at 2-4 ppm

Polyacrylate at 4-5 ppm

The above treatment regimen including acid treatment is what they used
at Scrubgrass.

For high hardness water such as in Arizona the COC limit for such a
system might be 3 but in the east it would be around 6-7. He said USGS
has a hardness map to get an idea of distribution nationwide (found at
HYPERLINK "http://water.usgs.gov/owq/hardness-alkalinity.html#hardness"
http://water.usgs.gov/owq/hardness-alkalinity.html#hardness ).

These chemicals are non-toxic and do not contain any of the priority
pollutants regulated in the steam generation effluent guidelines so they
should pose no problem with respect to direct discharge of cooling tower
blowdown.

There may be a small amount of COD. I asked about water quality and
phosphorus discharge – he said this could be a problem. For example he
was advising the PA DEP change their plans to use polyphoshates in their
office towers because it might not appear appropriate for the PA DEP to
be discharging Phosphorus into the Susquehanna when they are requiring
others to limit discharge of P

Each chemical would require a chemical feed pump which would be
relatively small in cost around several $1000 per pump.

They would also require costs of some labor for maintenance and the
chemist to run tests. Most power plants have an onsite chemist.

As described in his paper, they would also need to install a system to
control the cycles of concentration. The simplest and most reliable is
to install a meter on the makeup water which in turn controls the
blowdown pump such that blowdown is some fraction of makeup. The largest
cost would be for the meter which for the largest one he sells – 8 in
for up to 1430 gpm would cost $4,000. He said they generally use a rule
of thumb that installation will equal equipment costs

He said a full system including chemical feed and COC control for a
large 2000MW power plant might cost $20,000 to $25,000.

I also brought up side stream filtration. With regard to solids
particles in the <2 micron range are easily controlled with dispersants
like polyacrylate. Those in the >25 micron range can be controlled with
settling and cyclones etc. It is the solids in the 2-25 micron range
that are the most problematic and that multimedia filters are useful if
that is a problem. Most power plants don’t use filters but some may in
the future. He said a 1,000 gpm multimedia filter system would cost
about $250,000. I asked about disposal of solids backwash and he said
that at coal plants could easily be discharged to the ash pond.

Other benefits besides 316a & 3126b:

Chemical costs may be reduced if they are operating below the optimum
COC.

The addition of better chemical treatment can reduce corrosion of
equipment especially for the condensers by a factor of 5-6X. He said
some power plant operators disregard corrosion because they argue the
plant equipment is only expected to last 15 years.

Another benefit is that by substantially reducing the blowdown (applies
both to once-through and closed cycle), the discharge of biocide is
reduced since the volume is smaller and it is easier to treat (e.g.,
dechlorinate) smaller volumes. Same for other treatment chemicals since
blowdown volume is reduced.


SUPPORTING STATEMENT
For Renewal of Information Collection Requirements under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

40 CFR Part 6:
Procedures for Implementing the National Environmental Policy Act and
Assessing the Environmental Effects Abroad of EPA Actions

                OMB Control No. 2020-0033, EPA ICR No. 2243.10

Table of Contents
List of Acronyms	iv
1.	IDENTIFICATION OF THE INFORMATION COLLECTION	1
1(a)	Title of the Information Collection	1
1(b)	Abstract	1
2.	NEED FOR AND USE OF THE COLLECTION	3
2(a)	Need/Authority for the Collection	3
2(b)	Practical Utility/Users of the Data	3
3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA	4
3(a)	Nonduplication	4
3(b)	Public Notice Requirement Regarding ICR Submission to OMB	4
3(c)	Consultations	4
3(d)	Effects of Less Frequent Collection	5
3(e)	General Guidelines	5
3(f)	Confidentiality	5
3(g)	Sensitive Questions	5
4.	THE RESPONDENTS AND THE INFORMATION REQUESTED	6
4(a)	Respondents	6
4(b)	Information Requested	8
5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	11
5(a)	Agency Activities	11
5(b)	Collection Methodology and Management	12
5(c)	Small Entity Flexibility	12
5(d)	Collection Schedule	14
6.	ESTIMATING THE BURDEN OF THE COLLECTION	14
6(a)	Estimated Respondent Burden	14
6(b)	Estimated Respondent Costs	16
6(b)(i) Estimating Labor Costs	16
6(b)(ii) Estimating Capital and Operations and Maintenance Costs	16
6(b)(iii) Capital/Start-up Operating and Maintenance Costs	17
6(b)(iv) Annualizing Capital Costs	17
6(c)	Estimated Agency Burden and Cost	17
6(d)	Estimated Respondent Universe and Total Burden and Costs	18
6(e)	Bottom Line Burden Hours and Costs Tables	20
6(f)	Reasons for Change in Burden	21
6(g)	Burden Statement	21
PART B OF THE SUPPORTING STATEMENT	23
STATISTICAL SURVEY	23
ATTACHMENT 1 TO THE SUPPORTING STATEMENT	24
Exemptions from NEPA for Certain EPA Actions and the EPA's Voluntary
NEPA Policy and Procedures	24

List of Acronyms

CE			Categorical Exclusion
CEQ 			Council on Environmental Quality
CFR			Code of Federal Regulations
EA			Environmental Assessment
EID			Environmental Information Document
EIS			Environmental Impact Statement
EPA			Environmental Protection Agency
FONSI			Finding of No Significant Impact
FR			Federal Register
ICR			Information Collection Request
MPRSA		Marine Protection, Research, and Sanctuaries Act
NEPA			National Environmental Policy Act of 1969
NPDES		National Pollutant Discharge Elimination System
OMB			Office of Management and Budget
ROD			Record of Decision
STAG			State and Tribal Assistance Grants
USC			United States Code
WIFIA			Water Infrastructure Finance and Innovation Act
SUPPORTING STATEMENT
For Renewal of Information Collection Requirements under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

40 CFR Part 6:
Procedures for Implementing the National Environmental Policy Act and
Assessing the Environmental Effects Abroad of EPA Actions

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title of the Information Collection

"Procedures for Implementing the National Environmental Policy Act and Assessing the Environmental Effects Abroad of EPA Actions" (40 CFR Part 6); Office of Management and Budget (OMB) Control Number 2020-0033; EPA ICR Number 2243.10.

	1(b)	Abstract

The National Environmental Policy Act (NEPA), 42 U.S.C. 4321-4347, establishes a national policy for the environment. The Council on Environmental Quality (CEQ) oversees the NEPA implementation. The CEQ's NEPA implementation regulations at 40 CFR parts 1500 - 1508 set the standard for NEPA compliance. CEQ's NEPA regulations also require agencies to establish their own NEPA implementing procedures. The Environmental Protection Agency's (EPA) procedures for implementing NEPA are found in 40 CFR part 6. Through 40 CFR part 6, the EPA adopted the CEQ regulations and supplemented those regulations for actions proposed by the EPA that are subject to the NEPA requirements.
Compliance of the EPA's actions subject to 40 CFR part 6 is the responsibility of the EPA's Responsible Officials. For applicant-proposed actions, certain procedures apply to applicants (that is grantees and permit applicants) who must submit environmental information to the EPA as part of the environmental review process. The EPA Responsible Official is responsible for the environmental review process, including any categorical exclusion (CE) determination or the scope, accuracy, and contents of a final environmental assessment (EA) or environmental impact statement (EIS) and any supporting documents. The applicant contributes by submitting environmental information to the EPA as part of the environmental review process. The applicant may submit information to the Responsible Official regarding the applicability of a CE and request a determination by the Responsible Official. If the applicant-proposed action is not eligible for a CE, the Responsible Official may gather information and prepare the NEPA documents without assistance from the applicant, or have the applicant prepare an environmental information document (EID) or a draft EA and supporting documents or implement a third-party contract agreement with the applicant.
40 CFR part 6 also includes the EPA's procedures, "Assessing the Environmental Effects Abroad of EPA Actions," that implement Executive Order 12114, "Environmental Effects Abroad of Major Federal Actions" (see 46 FR 3364). The EPA's Executive Order 12114 procedures further the purpose of NEPA and provide that the EPA may be guided by its NEPA procedures to the extent they are applicable. Therefore, when the EPA conducts an EA pursuant to its Executive Order 12114 procedures, the Agency generally follows its NEPA procedures. Compliance with the procedures is the responsibility of the EPA's Responsible Officials and for applicant-proposed actions, applicants may be required to provide environmental information to the EPA as part of the environmental review process.
This request renews the "Procedures for Implementing the National Environmental Policy Act and Assessing the Environmental Effects Abroad of EPA Actions" ICR by updating the information contained in the previously approved ICR for 40 CFR part 6.
2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

The CEQ NEPA regulations (40 CFR 1507.3) require federal agencies to adopt and, as needed, revise their own implementing procedures to supplement the CEQ NEPA regulations. The purpose of 40 CFR part 6 is to satisfy the procedural requirements of the CEQ NEPA regulations that are applicable to the EPA actions. Additionally, 40 CFR part 6 includes the EPA's environment review procedures implementing Executive Order 12114. The EPA is collecting information from certain applicants as part of the process of complying with either NEPA or Executive Order 12114 per 40 CFR part 6.

	2(b)	Practical Utility/Users of the Data

The EPA's NEPA regulations apply to the actions of the EPA that are subject to NEPA to ensure that environmental information is available to the Agency's decision-makers and the public before decisions are made and before actions are taken. This includes actions such as wastewater treatment construction grants under section 201 of the Clean Water Act, the EPA's issuance of new source National Pollutant Discharge Elimination System (NPDES) permits as defined in section 306 of the Clean Water Act, certain research and development projects, the EPA actions involving renovations at or new construction of EPA facilities, water and wastewater infrastructure projects funded under the Water Infrastructure Finance and Innovation Act (WIFIA), and certain grants awarded for projects authorized by Congress through the Agency's annual appropriations act. The EPA actions subject to NEPA that are based on applicant proposals may include any of these except the EPA actions for construction of special purpose facilities or facility renovations of EPA facilities. The 40 CFR part 6 also include the EPA's procedures implementing Executive Order 12114. These procedures ensure that environmental information is available to the Agency's decision-makers and other appropriate federal agencies and officials for actions subject to Executive Order 12114.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Nonduplication

For both the NEPA and Executive Order 12114 implementing procedures, the information submitted by an applicant does not duplicate information otherwise submitted to the government. For an EPA action subject to NEPA that is based on an applicant proposal, the applicant (e.g., grantee or permit applicant) would submit information used by the Responsible Official during the environmental review process. This one-time submission is specific to the applicant's proposed action to provide project-specific information necessary for the Responsible Official's environmental review of the proposed action.

	3(b)	Public Notice Requirement Regarding ICR Submission to OMB

The Office of Federal Activities published a Notice in the Federal Register for this ICR renewal on June 28, 2022, during a 60-day comment period. The notice requested public comments on the Agency's need for the information outlined in this ICR, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.
The EPA established a public docket for this ICR renewal under Docket ID number EPA-HQ-OA-2019-0296. The EPA requested that any comments related to this ICR renewal be submitted to the EPA. The EPA's docket is available online at regulations.gov and through the EPA Docket Center  -  Public Reading Room, William Jefferson Clinton (WJC) West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. 20004. The public may use the public docket to obtain a copy of the ICR including the Supporting Statement, review public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically.

	3(c)	Consultations

The EPA actions subject to NEPA or Executive Order 12114 that are based on applicant proposals are one-time only and involve various government jurisdictions and businesses rather than repeated requests for information from specific government jurisdictions and businesses. The EPA relied on information available from its NEPA practitioners and their experience working with grantees and permit applicants to prepare the burden estimates in this ICR. These are the same EPA practitioners that conduct the assessments of applicant-proposed actions subject to NEPA or Executive Order 12114 as further discussed in Section 4(a) of this Supporting Statement. The NEPA practitioners stated that they felt that the amount and frequency of information required was appropriate for the environmental reviews. They did not provide suggestions of how to enhance the quality, utility and clarity of information, or suggestions of how to minimize the burden on the public.

	3(d)	Effects of Less Frequent Collection

Under 40 CFR part 6, respondents submit project-specific information only for the EPA actions subject to NEPA or Executive Order 12114 that are based on applicant proposals (as further discussed in Section 4(a)). Such actions are generally one-time requests from the EPA for environmental information from applicants requesting grant assistance for specific projects subject to NEPA or for new source NPDES permits to be issued by the EPA. There are no ongoing or periodic reporting or recordkeeping requirements.

	3(e)	General Guidelines

The information submitted by applicants would be consistent with the guidelines of the OMB in 5 CFR 1320.5(d)(2). For an applicant-proposed action, the applicant (e.g., grantee or permit applicant) submits information to the EPA's Responsible Official as part of the environmental review process. This is a one-time submission specific to the applicant's proposed action to provide project-specific information necessary for the environmental review of the proposed action. The Responsible Official, however, may ask the applicant to provide additional information if the Responsible Official needs it to prepare the EA or EIS. There are no schedule requirements or requirements on the number of copies of the documentation to be submitted or requirements for ongoing reporting or recordkeeping or to conduct statistical surveys.

	3(f)	Confidentiality

40 CFR part 6 does not require applicants to submit confidential, proprietary or trade secret information.

	3(g)	Sensitive Questions

40 CFR part 6 does not require applicant response to sensitive questions (e.g., questions concerning sexuality, religious beliefs, or other matters usually considered private).

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents

Those subject to 40 CFR part 6 includes the EPA officials who must comply with NEPA or Executive Order 12114, and certain grant or permit applicants who must submit an EID to the EPA for their projects. For purposes of delineating the information collection requirements under the PRA, 44 U.S.C. 3501 et seq., "applicants" (e.g., grantees or permit applicants) are the respondents (e.g., the persons who must generate, maintain, or provide information to or for a federal agency).
The EPA actions generally subject to NEPA include wastewater treatment construction grants under section 201 of the Clean Water Act, issuance of new source NPDES permits by the EPA, certain research and development grants, the EPA actions for construction of special purpose facilities or facility renovations of EPA facilities, water and wastewater infrastructure projects funded under the WIFIA, and certain grants awarded for projects authorized by Congress through the Agency's annual appropriations act. The EPA actions subject to NEPA that are based on applicant proposals may include any of these except the EPA actions for construction of special purpose facilities or facility renovations of EPA facilities. The EPA Responsible Official is responsible for the environmental review process, including any categorical exclusion determination or the scope, accuracy, and contents of a final EA or EIS and any supporting documents. The applicant may contribute by submitting environmental information to the EPA as part of the environmental review process.
The EPA actions typically subject to Executive Order 12114 include major EPA actions which affect the environment of a foreign nation or the global commons and may include: major research or demonstration projects, ocean dumping activities carried out under section 102 of the Marine Protection, Research, and Sanctuaries Act (MPRSA) (33U.S.C. 1401 et seq.), major permitting or licensing of facilities by the EPA, Wastewater Treatment Construction Grant Program under section 201 of the Clean Water Act when activities addressed in the facility plan would have environmental effects abroad, and other EPA activities as determined by the EPA.
Wastewater Treatment Construction Grants Program facilities under section 201 of the Clean Water Act or new source NPDES permits to be issued by the EPA for facilities in the U.S. bordering Mexico or Canada are subject to the EPA's NEPA implementing procedures. If these facilities could have significant environmental effects abroad, generally they would also be subject to the EPA's procedures implementing Executive Order 12114. In addition, the EPA has determined that certain grants awarded for projects authorized by Congress through the Agency's annual appropriations act are subject to NEPA. Typically, these are state and tribal assistance grants (STAG) that involve projects in the U.S. bordering Mexico or Canada that could have significant environmental effects abroad and generally would be subject to the EPA's procedures implementing Executive Order 12114.
Further, certain actions subject to the EPA's Executive Order 12114 implementing procedures are not subject to the EPA's NEPA implementing procedures. As with the EPA's current part 6 regulations, the EPA's Executive Order 12114 implementing procedures  provide that: (a) for ocean dumping activities, the information submitted under 40 CFR part 221 is sufficient to satisfy the environmental assessment requirements; and (b) for permits issued under section 3005 of the Resource Conservation and Recovery Act, section 402 of the Clean Water Act, and section 165 of the Clean Air Act, the information submitted by applicants for such permits or approvals under the applicable consolidated permit regulations (40 CFR parts 122 and 124) and Prevention of Significant Deterioration regulations (40 CFR part 52) satisfy the environmental document requirements of Executive Order 12114.
In summary, the applicant burden for any applicant-proposed actions, including permitting or licensing, under these authorities is already addressed under the EPA's ICRs for these programs and is not further addressed in this ICR. However, the applicant burden for any EPA action subject to NEPA and/or Executive Order 12114 that is based on an applicant proposal, including STAG actions subject to NEPA and new source NPDES permits issued by the EPA, is addressed in this ICR. The EPA's Executive Order 12114 implementing procedures further the purpose of NEPA and provide that the EPA may be guided by the CEQ regulations to the extent they are applicable. Therefore, when the EPA conducts an EA pursuant to its Executive Order 12114 procedures, the Agency generally follows the CEQ regulations and the procedures in the EPA's NEPA implementing regulations. For these reasons, for applicant-proposed actions subject to either NEPA or Executive Order 12114 (and that are not addressed in other EPA programs' ICRs), the remainder of this ICR Supporting Statement will evaluate the respondent burden only with regard to the EPA's NEPA implementing procedures.
For purposes of this ICR, the EPA considers the model respondents to be two types of applicants:
 Grant applicants applying to the EPA for funding of projects identified in the STAG account authorized by Congress through the Agency's annual appropriations act. These applicants are generally governmental jurisdictions.
 Permit applicants applying to the EPA for issuance of new source NPDES permits under section 402 of the Clean Water Act. Because of the large number of facilities requiring permits, the EPA issues general permits for certain discharges. A general permit is an NPDES permit that covers multiple facilities that have similar discharges and are in a specific geographic area. A general permit applies the same or similar conditions to all dischargers covered under the general permit. Using a general permit to cover numerous facilities reduces paperwork for permitting authorities and permittees and ensures consistency of permit conditions for similar facilities.

	4(b)	Information Requested

For the EPA actions subject to NEPA, the Responsible Official may determine that the proposed action does not individually or cumulatively have a significant effect on the human environment and may, therefore, be categorically excluded from further NEPA review. If the proposed action is not categorically excluded, the Responsible Official may prepare an EA to determine whether to prepare an EIS or a FONSI. The Responsible Official prepares an EIS if the proposed action will have a significant effect on the human environment. For the EPA actions subject to NEPA that are based on applicant proposals, the Responsible Official may gather the information and prepare the NEPA documents without environmental information submitted by the applicant, or have the applicant prepare an EID, or a draft EA and supporting documents, or implement a third-party agreement with the applicant.
The level of NEPA documentation and the project-specific information the Responsible Official needs for decision-making is determined by the potential for environmental impact of the action, or the facility to be permitted or the project to be funded by the action rather than the dollar amount of the project or whether the applicant is a grantee or permit applicant. Table 1 summarizes the information to be submitted by an applicant for a CE determination, an EA and FONSI, and an EIS and Record of Decision (ROD). There are no schedule requirements or requirements on the number of copies of the information document to be submitted or requirements for ongoing reporting or recordkeeping.

Table 1. Summary of Information Submitted by Applicants for CEs, EAs/FONSIs, and EISs/RODs
Categorical Exclusion (CE) means a category of actions which do not individually or cumulatively have a significant effect on the human environment and have been found by the EPA to have no such effect. To find that a proposed action is categorically excluded, the Responsible Official needs to determine that the proposed action fits within a CE that is listed in the regulations, and the proposed action does not involve any extraordinary circumstances as listed in the regulations. "Extraordinary circumstances" mean those circumstances in which a normally excluded action may have a significant environmental effect. Based on review of information in the applicant's application and other available information, the Responsible Official notifies the applicant if the action is categorically excluded, or if the EPA needs additional information to support the application of a categorical exclusion.
Information Submitted by Applicant: The applicant may provide statements or documents to the Responsible Official to verify that the proposed action would not involve any of the listed extraordinary circumstances.
 For example, the applicant might submit information to support a categorical exclusion determination for an action that meets the criteria for "actions in unsewered communities relating to the use of proposed wastewater on-site technologies where such technologies replace existing systems." If the project area is known to be near a property with nationally significant historic value, the applicant would likely enclose a letter from the State Historic Preservation Officer that confirms the proposed project will not have a significant environmental effect on the historic property. The applicant letter may also verify there are no wetlands in the project area.
Environmental Assessments (EAs) need to include sufficient information and analysis for the Responsible Official to determine whether to prepare an EIS or to issue a FONSI.
Information Submitted by Applicant: The applicant submits an EID of sufficient scope to enable the Responsible Official to prepare an EA, and then determine whether to issue a FONSI or prepare an EIS. At the discretion of the Responsible Official, the applicant may prepare a draft EA and supporting documents in lieu of an EID.
 An EID for an EA, or a draft EA and supporting documents, generally will: (1) include brief discussions of the need for the proposed action; the alternatives, including the no action alternative; description of the affected environment; and the environmental impacts of the proposed action and alternatives; (2) include a listing or summarize any coordination or consultation undertaken with any federal agency, state or local government, or federally-recognized Indian tribe, including compliance with applicable laws and executive orders; (3) identify and describe any mitigation measures that must be considered, including any mitigation measures that must be adopted to ensure the action will not have significant impacts; and (4) incorporate documents by reference.
Environmental Impact Statements (EISs) are generally prepared for major actions that may significantly affect the quality of the human environment, or when an EA indicates that significant impacts may occur that cannot be reduced or eliminated by changes to or mitigation of the proposed action. A ROD documents the decision of the Responsible Official.
Information Submitted by Applicant: The applicant submits an EID of sufficient scope to enable the Responsible Official to prepare an EIS and ROD. In lieu of submitting documentation, the Responsible Official and the applicant may enter into a third-party contract agreement. The information needed for an EIS parallels the information needed for an EA with a focus on assessment of significant environmental issues and alternatives.
 An EID for an EIS generally will: (1) provide the EPA with information the agency will use to prepare an EIS; (2) analyze all reasonable alternatives and the no action alternative; (3) describe the potentially affected environment including, as appropriate, the size and location of new and existing facilities, land requirements, operation and maintenance requirements, auxiliary structures such as pipelines or transmission lines, and construction schedules; (4) summarize any coordination or consultation undertaken with any federal agency, state or local government, or federally-recognized Indian tribe, including compliance with applicable laws and executive orders; (5) the draft EIS must summarize any public meetings during the scoping process, and the final EIS must summarize the public participation process held after publication of the draft EIS; (6) the draft EIS must consider substantive comments received during the scoping process, and the final EIS must summarize all comments on the draft EIS and respond to any substantive comments and explain any changes to a revised draft EIS or the final EIS and the reasons for the changes; and (7) include the names and qualifications of the persons primarily responsible for preparing the EIS including significant background papers.

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

Compliance with the regulations is the responsibility of the EPA's Responsible Officials. For applicant-proposed actions, grantees or permit applicants must submit environmental information to the EPA as part of the environmental review process unless the Responsible Official decides to prepare the NEPA documents without assistance from the applicant. As noted in Table 1 above, the Responsible Official may determine that the action is categorically excluded; prepare an EA to determine whether to issue a FONSI; or prepare an EIS and ROD.

	5(b)	Collection Methodology and Management

Whether the NEPA documents are based on environmental information developed by the Responsible Official or submitted by the applicant, the NEPA review and resulting documents generally rely on the use of existing data and information, including data and information from other federal agencies, state or local governments, or federally recognized Indian tribes with jurisdiction by law or special expertise.
Whether the NEPA documents are prepared by the Responsible Official or based on environmental information submitted by the applicant, the quality of the information provided by an applicant must be sufficient to enable the Responsible Official to make a decision. This is accomplished under the EPA's NEPA implementing procedures through: (1) early coordination and cooperation with federal agencies, state and local governments, and federally recognized Indian tribes with jurisdiction by law or special expertise (see 40 CFR 6.202); and (2) the public participation process associated with actions other than those categorically excluded (see 40 CFR 6.203). When the environmental information is provided by the applicant, the Responsible Official is responsible for the statements, analyses, and conclusions of the EA or EIS and any supporting documents.
The information compiled is a one-time submission in narrative text format (see 40 CFR 6.205 and 6.207) rather than computerized compilations of data and information. There are no forms, checklists, or ongoing reporting, recordkeeping or file-maintenance requirements for applicants (see Subpart C). The EPA maintains file records for each action.

      5(c)	Small Entity Flexibility

The information collected under this ICR is one-time only for applicant-proposed actions, e.g., actions proposed by grantees seeking funding assistance from the EPA or for an NPDES permit application initiated by the permit applicant. In either case, the EPA assumes the action will directly benefit the applicant (such as a grantee seeking grant funding for renovation of a community drinking water system, or a permit applicant seeking a new source NPDES permit from the EPA to further the applicant's business interests). Nonetheless, if the applicant cannot afford to provide the required environmental information to the EPA, then the EPA would undertake the environmental review without input from the applicant. Further, grantees may be grant-eligible for certain costs associated with providing environmental information to the EPA. Permit applicants are not eligible for the EPA financial assistance.
The EPA has reduced the burden on small entities (including businesses and government jurisdictions) through the following provisions in the EPA's NEPA implementing procedures:
 Section 6.300: An EID is not required when the action is categorically excluded, or the applicant will prepare a draft EA and supporting documents. The Responsible Official may prepare the NEPA documents without environmental information submitted by the applicant.
 Section 6.302:
 The Responsible Official may prepare generic guidance for categories of actions involving a large number of applicants; and must ensure early involvement of applicants, consult with the applicant and provide guidance describing the scope and level of environmental information required, and provide guidance on a project-by-project basis to any applicant seeking assistance.
 The Responsible Official must consider the extent to which the applicant is capable of providing the required information, may not require the applicant to gather data or perform analyses that unnecessarily duplicate either existing data or the results of existing analyses available to the EPA, and must limit the request for environmental information to that necessary for the environmental review.
 Section 6.303: An applicant may enter into a third-party agreement with the EPA. (For grantees, certain third-party contractor costs may be eligible for cost reimbursement; see footnote 10. However, new source NPDES permit applicants are not eligible for the EPA financial assistance.)

	5(d)	Collection Schedule

Information must be submitted by an applicant only for the EPA actions subject to NEPA that are based on applicant proposals unless the EPA will prepare the NEPA documents without environmental information submitted by the applicant. The information to be submitted is required only when an applicant applies for a grant for an action subject to NEPA or a new source NPDES permit to be issued by the EPA, a one-time application process. The Responsible Official, however, may ask the applicant to provide additional information if the Responsible Official needs it to prepare the EA or EIS. There are no schedules in the regulations for this collection process.

6.	ESTIMATING THE BURDEN OF THE COLLECTION

The content of the environmental information submitted by an applicant for a draft EA and supporting documents and an EID for a draft EA and supporting documents is similar. There may be a financial difference for grantees in that the EPA financial assistance generally may be used to prepare an EID but not to prepare a draft EA and supporting documents (see footnote 10). New source NPDES permit applicants are not eligible for the EPA financial assistance. The applicant may also enter into a third-party agreement whereby the applicant engages and pays for the services of a contractor to prepare the draft EA and supporting documents.
The content of the environmental information submitted by an applicant for a draft EIS and supporting documents and an EID for a draft EIS and supporting documents is similar. For grantees, third-party contractor costs may be eligible for cost reimbursement (see footnote 10). New source NPDES permit applicants are not eligible for the EPA financial assistance. Although an applicant may contract for preparation of an EID for a draft EIS, because EISs are generally more complex than EAs in terms of the issues to be addressed and the associated analyses, it has generally been the EPA's experience that applicants will enter into a third-party agreement with the EPA for preparation of the EIS and supporting documents.

	6(a)	Estimated Respondent Burden

For an EPA action subject to NEPA that is based on an applicant proposal, the applicant would generally submit information to the EPA Responsible Official as part of the environmental review process as delineated in Section 4(b), Table 1. As noted above, the EPA assumes the applicant will use a contractor to compile and prepare the environmental information to be submitted to the Responsible Official. For the applicant, the burden includes the time and costs needed to:
 Procure contractor services.
 Review instructions (such as the regulations and any program-specific guidelines the Responsible Official may also provide) and/or meet with the Responsible Official.
 Research data sources.
 Complete and review the collection of environmental information.
 Transmit the information to the Responsible Official.
 Meet with the Responsible Official on the need for any revisions to the environmental information and prepare and submit any necessary revisions to the information.
The applicant would not be required to develop, acquire, install, or 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; or train personnel to be able to respond to a collection of information; nor would there be requirements for ongoing reporting or recordkeeping.
An estimation of the hours per document type is provided below and is included in Section 6(d), Table 4.
 For CEs, the EPA estimates that applicants may use 50 hours per project to prepare any supplemental information requested by the EPA to prepare the CE documentation.
 For EAs, the EPA estimates that applicants may use 260 hours per project to prepare any supplemental information or EID requested by the EPA for the EA documentation.
 For EISs, the EPA estimates that applicants may use 2,840 hours per project to prepare any supplemental information or EID requested by the EPA for the EIS documentation.
The number of respondents by application type are presented below.

Table 2. The number of annual respondents by application type.
Type of Information
Number of Grant Respondents
Number of Permit Respondents
CE
                                      310
                                       2
EA/FONSI
                                      200
                                       2
EIS/ROD
                                      1*
                                      1*
                                                                         TOTALS
                                      511
                                       5
* The EPA estimates one project will have an EIS/ROD completed during the three-year life of this ICR. For this table, the number of respondents for an EIS/ROD has been calculated annually.

	6(b)	Estimated Respondent Costs

      6(b)(i) Estimating Labor Costs

Grantee applicants are assumed to be state and local government or federally-recognized Indian tribes. Permit applicants are assumed to be civilian worker applicants. Using the national mean wage estimates for management and professional occupations derived from the Bureau of Labor Statistics, the EPA estimated wage for grant and permit applicants is as follows:
 Applicant Wage Rate: $59.31 x 1.43 = $84.81 per hour

      6(b)(ii) Estimating Capital and Operations and Maintenance Costs

Start-up costs for the NEPA documentation for the EPA grant or permit applications and associated forms are minimal and are part of customary and usual recipient business expenses. There are no capital costs related to the NEPA documentation for the EPA grant or permit applications and related reporting requirements.

      6(b)(iii) Capital/Start-up Operating and Maintenance Costs

There are no capital costs related to the NEPA documentation for the EPA grant or permit applications and related reporting requirements. There are no operating and maintenance costs required.

      6(b)(iv) Annualizing Capital Costs

This subsection is not applicable.

	6(c)	Estimated Agency Burden and Cost

For the EPA actions subject to NEPA that are based on grant or permit applicant proposals, the EPA may: (1) prepare the NEPA documents without assistance from the applicant; or (2) prepare the NEPA documents based on information submitted by the applicant (and any other supplemental information).
 The EPA Wage Rate: $55.33 per hour
 For CEs, the EPA estimates it prepares CE documentation based on the information in the grant or permit application and supplemental information gathered directly by the EPA using about 50 hours per project.
 For EAs, the EPA estimates it prepares the documentation based on the information in the grant or permit application and supplemental information gathered directly by the EPA using an estimated 120 hours.
 For EISs, the EPA estimates it prepares the documentation based on the information in the grant or permit application and supplemental information gathered directly by the EPA using an estimated 530 hours. The EPA estimated that one EIS/ROD may be required during the three-year life of this ICR.

Table 3. One-Time, Annual Estimated Burden and Cost for the EPA
EPA
Information Type
                         HOURS AND COST PER RESPONDENT
                             TOTAL HOURS AND COSTS

EPA Hours/Year
Labor Cost/Year
O & M Cost
Number of Respondents
Total Hours/Year
Total Costs/Year
Grants
CE
50
$2,767
$0
310
15,500
$857,770

EA/FONSI
120
$6,640
$0
200
24,000
$1,328,000

EIS/ROD*
530
$29,325
$0
1
530
$29,325
Permits
CE
50
$2,767
$0
2
100
$ 5,532

EA/FONSI
120
$6,640
$0
2
240
$13,280

EIS/ROD*
530
$29,325
$0
1
530
$29,325
                                   Subtotals
1,400
$77,464
$0
516
40,900
$2,263,232
* The EPA estimates one project will have an EIS/ROD completed during the three-year life of this ICR. For this table, the cost and hour estimates have been calculated annually.

	6(d)	Estimated Respondent Universe and Total Burden and Costs

The information collected under this ICR is one-time only for the EPA actions subject to NEPA that are based on applicant proposals. Grantees or permit applicants must submit environmental information to the EPA as part of the environmental review process unless the Responsible Official decides to prepare the NEPA documents without assistance from the applicant. If the applicant cannot afford to provide the required environmental information to the EPA, then the EPA would undertake the environmental review without input from the applicant (see footnote 9). Further, grantees may be grant-eligible for certain costs associated with providing environmental information to the EPA (see footnote 10); permit applicants are not eligible for the EPA financial assistance.
 For CEs, the EPA estimates that applicants may use 50 hours per project to prepare any supplemental information requested by the EPA to prepare the CE documentation.
 For EAs, the EPA estimates that applicants may use 260 hours per project to prepare any supplemental information or EID requested by the EPA for the EA documentation.
 For EISs, the EPA estimates that applicants may use 2,840 hours per project to prepare any supplemental information or EID requested by the EPA for the EIS documentation.
Grant Applicants: Respondents are those who apply to the EPA for funding of projects identified in the STAG account authorized by Congress through the agency's annual appropriations act. These applicants are generally governmental jurisdictions. Such grants are authorized by Congress, and subsequently awarded by the EPA. Specifically, STAG account actions subject to NEPA and addressed in this ICR include congressional earmarks. As of 2010, earmarks under the STAG account have not been awarded. However, in the 2022 annual appropriations act, Congress authorized congressionally directed spending projects (earmarks). The EPA anticipates that approximately 1,500 NEPA documents will be completed for the congressionally directed spending grants during the three-year life of this ICR, with approximately 500 requiring documentation completed annually. The EPA estimates that 300 of the earmark projects will be documented with a CE, and about 200 projects with an EA/FONSI. The EPA has not issued an EIS/ROD for a grant under the STAG account in the past twelve years and assumes no EIS will be prepared in the next three years. However, for purposes of this ICR, the EPA estimated that one EIS/ROD may be required during the three-year life of this ICR. In addition, the EPA anticipates that approximately 10 grants will be documented annually with a CE for the Title II wastewater treatment construction grant program.
Permit Applicants: Respondents are those who also apply to the EPA for issuance of new source NPDES permits under Section 402 of the Clean Water Act. The EPA issues new source NPDES permits only in states and U.S. territories that have not assumed authority for this program (see Section (4(a)). Because most states have assumed the NPDES program, few new source NPDES permits are issued by the EPA. Initially, these projects are documented with EAs/FONSIs. Actions involving re-issuance of a NPDES permit for a new source may be categorically excluded providing the conclusions of the original NEPA document remain valid (including the appropriate mitigation), there will be no degradation of the receiving waters, and the permit conditions do not change or are more environmentally protective (see 40 CFR 6.205(a)(1)(iv)). As such, the EPA anticipates that 13 NEPA documents will be completed for new-source NPDES permits during the three-year life of this ICR. For the three-year life of this ICR, the EPA estimates that annually that two projects will be documented by a CE; two projects will be documented with an EA/FONSI. The EPA estimated that one EIS/ROD may be required during the three-year life of this ICR.

Table 4. One-Time, Annual Estimated Burden Hours and Costs for Grant and Permit Applicants
Respondent
Information Type
                        HOURS AND COSTS PER RESPONDENT
                             TOTAL HOURS AND COSTS

Respondent Hours/Year
Labor Cost/Year
O & M Cost
Number of Respondents
Total Hours/Year
Total Costs/Year
Grants
CE
50
$4,241
$0
310
15,500
$1,314,710

EA/FONSI
260
$22,051
$0
200
52,000
$4,410,200

EIS/ROD*
2,840
$240,860
$0
1
2840
$240,860
Permits
CE
50
$4,241
$0
2
100
$8,482

EA/FONSI
260
$22,051
$0
2
520
$44,102

EIS/ROD*
2,840
$240,860
$0
1
2840
$240,860
                                   Subtotals
6,300
$534,304
$0
516
73,800
$6,259,214
*The EPA estimates one project will have an EIS/ROD completed during the three-year life of this ICR. For this table, the cost and burden hour estimates have been calculated annually.

	6(e)	Bottom Line Burden Hours and Costs Tables

The information collected under this ICR is one-time only on a per-project basis for the EPA actions subject to NEPA that are based on applicant proposals. Grantees or permit applicants submit environmental information to the EPA as part of the environmental review process unless the Responsible Official decides to prepare the NEPA documents without assistance from the applicant. The NEPA review for a project may result in a CE, or an EA/FONSI, or an EIS/ROD. For any specific project, only one of these levels of documentation is generally prepared. Based on the EPA's experience, most projects annually will be documented with a CE. In addition, the EPA estimates that one project will have an EIS/ROD completed during the three-year life of this ICR.

Table 5. Summary of Aggregate Total Annual Estimated Costs and Hours for Applicants and the EPA

Burden Hours
Cost
Respondents
73,800
$6,259,214
EPA
40,900
$2,263,232

	6(f)	Reasons for Change in Burden

The overall respondent burden has increased from the previous ICR by 66,240 hours (from 7,560 hours to 73,800 hours). This adjustment occurred due to a significant increase in size of the respondent universe as a result of the return of congressional earmarks in the EPA annual appropriation act. The EPA carefully reviewed the grant and permit programs covered by this ICR to obtain an accurate reflection of the number of projects that may require NEPA documentation (CE, EA/FONSI, EIS/ROD). This information was collected from the EPA program offices, the EPA NEPA compliance database [https://cdxapps.epa.gov/cdx-enepa-II/public/action/nepa/search], and the EPA EIS database [https://cdxapps.epa.gov/cdx-enepa-II/public/action/eis/search].

      6(g)	Burden Statement

The annual public reporting and recordkeeping burden for this collection of information is estimated at 27,004 hours. This burden reflects an annual one-time submission of documentation for an anticipated 516 applicant-proposed projects that may be documented with a CE, or an EA/FONSI, or an EIS/ROD. Under the ICR renewal, the EPA assumes there will be approximately 510 grantee projects annually with about 310 of these projects documented with a CE, and about 200 with an EA/FONSI. For permit applicants, the EPA assumes there will be approximately five projects annually with about two documented with a CE, two documented with an EA/FONSI, and one project will have an EIS/ROD once every three-years.
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; research 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 the EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
 To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID Number [EPA-HQ-OA-2019-0296 (previously EPA-HQ-OECA-2005-0062)], which is available for online viewing at www.regulations.gov, or in person viewing at the Office of the Administrator docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. 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 for the Office of the Administrator docket is<PHONE_NUMBER>. An electronic version of the public docket is available at www.regulations.gov. This site can be used to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. When 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, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID Number EPA-HQ-OA-2019-0296 and OMB Control Number 2020-0033 in any correspondence.

	PART B OF THE SUPPORTING STATEMENT
	STATISTICAL SURVEY

This collection of information does not use or is otherwise based on a statistical survey.

	ATTACHMENT 1 TO THE SUPPORTING STATEMENT

      Exemptions from NEPA for Certain EPA Actions and the EPA's Voluntary NEPA Policy and Procedures

Exemptions from NEPA for Certain EPA Actions
Certain EPA actions are exempt from the procedural requirements of NEPA, and thus are also exempt from the CEQ NEPA regulations. Congress has provided specific statutory exemptions for most EPA actions taken under the Clean Water Act and all EPA actions taken under the Clean Air Act from the procedural requirements of NEPA, including the CEQ NEPA Regulations. Specifically, under Section 511(c)(1) of the Clean Water Act (33 U.S.C. 1371), the EPA is exempt from the procedural requirements of NEPA for all actions taken under the Act except for issuance of National Pollution Discharge Elimination System permits under Section 402 for "new sources" as defined in Section 306 of the Clean Water Act (33 U.S.C 1342), and Federal financial assistance for the construction of publicly owned treatment works under Section 201 of the Clean Water Act (33 U.S.C. 1281). Under the Energy Supply and Environmental Coordination Act of 1974 (15 U.S.C. 793(c)(1)), all actions taken under the Clean Air Act are deemed not to be major Federal actions significantly affecting the environment The EPA is also exempted from the procedural requirements of environmental laws, including NEPA, for the Comprehensive Environmental Response, Compensation, and Liability Act response actions. See Section 121(d)(2)(A) of the Act, as interpreted by the EPA in 40 CFR 300.5 and 300.400(g).
Further, the courts have exempted certain EPA actions from the procedural requirements of NEPA based on the functional equivalence doctrine. Under the functional equivalence doctrine, courts have found the EPA to be exempt from the procedural requirements of NEPA for certain actions under the Federal Insecticide, Fungicide, and Rodenticide Act, the Resource Conservation and Recovery Act, the Toxic Substances Control Act, the Safe Drinking Water Act, and the Marine Protection, Research, and Sanctuaries Act. The courts reasoned that the EPA actions under these statutes perform the functionally equivalent of a NEPA review because they are undertaken with consideration of environmental impacts and opportunities for public involvement. See, e.g., Merrill v. Thomas, 807 F.2d 776 (9[th] Cir. 1986); State of Alabama v. EPA, 911 F. 2d 499 (11[th] Cir. 1990); Warren County v. North Carolina, 528 F. Supp. 276 (E.D. N.C. 1981); Western Nebraska Resources Council v. US EPA, 943 F.2d 867 (8[th] Cir. 1991); Maryland v. Train, 415 F. Supp. 116 (D. Md. 1976).

The EPA's Voluntary NEPA Policy and Procedures
The Agency's current "Statement of Policy for Voluntary Preparation of National Environmental Policy Act (NEPA) Documents" (see 63 FR 58045) sets out the policy and procedures the EPA uses when voluntarily preparing environmental review documents in situations when doing so would be helpful to decision-making.


[Federal Register: July 8, 2009 (Volume 74, Number 129)]
[Notices]
[Page 32579-32580]
[DOCID:fr08jy09-52]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2008-0366; FRL-8926-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Coke Oven Pushing
Quenching and Battery Stacks (Renewal), EPA ICR Number 1995.04, OMB
Control Number 2060-0521

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

DATES: Additional comments may be submitted on or before August 7,
2009.

ADDRESSES: Submit your comments, referencing docket ID number EPA-OECA-
2008-0366, to (1) EPA online using www.regulations.gov (our preferred
method), or by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center (EPA/DC), Environmental Protection Agency, Enforcement and
Compliance Docket and Information Center, mail code 22881T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB at: Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Sounjay Gairola, Office of Enforcement
and Compliance Assurance, Mail Code 2242A, Environmental Protection
Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On May 30, 2008 (73 FR 31088), EPA sought comments on this ICR
pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2008-0366, which is available for public viewing
online at http://www.regulations.gov and in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Reading Room is<PHONE_NUMBER>, and the telephone number
for the Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov, as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NESHAP for Coke Oven Pushing Quenching and Battery Stacks
(Renewal).
    ICR Numbers: EPA ICR Number 1995.04, OMB Control Number 2060-0521.
    ICR Status: This ICR is scheduled to expire on August 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Coke Oven Pushing Quenching and Battery Stacks
(40 CFR Part 63, Subpart CCCCC) were promulgated on April 14, 2003.
    The affected entities are subject to the General Provisions of the
NESHAP at 40 CFR part 63, subpart A, and any changes, or additions to
the General Provisions specified at 40 CFR part 63, subpart CCCCC.
    Owners or operators of the affected facilities must submit a one-
time-only report of any physical or operational changes, initial
performance tests, and periodic reports and results. Owners or
operators are also required to maintain records of the occurrence and
duration of any startup, shutdown, or malfunction in the operation of
an affected facility, or any period during which the monitoring system
is inoperative. Reports, at a minimum, are required semiannually.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 229
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Coke oven pushing quenching and
battery stacks.
    Estimated Number of Respondents: 19.
    Frequency of Response: Initially, occasionally, weekly, quarterly
and semiannually.
    Estimated Total Annual Hour Burden: 25,879.
    Estimated Total Annual Cost: $2,361,375: which is comprised of
$2,191,875 in labor costs, $169,500 in O&M costs, and no annualized
capital/startup costs.
    Changes in the Estimates: There is no change in the basis for labor
hours or cost to the respondents in this ICR compared to the previous
ICR. This is due to two considerations: (1) The regulations have not
changed over the past three years and are not anticipated to change
over the next three years; and

(2) the growth rate for respondents is very low, negative, or non-
existent. The previous approved ICR renewal indicated 30 annual
responses; after review of the previous supporting statement, it was
determined that the number of indicated responses was an error. The
total number of annual responses is 113. Additionally, there was a
calculation error in the previous estimation of labor hours. The slight
increase in burden is due to a correction in the total labor burden
from 25,208 to 25,879 per year.

    Dated: June 30, 2009.
John Moses,
Director, Collection Strategies Division.
[FR Doc. E9-16007 Filed 7-7-09; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Page 12193]
[FR Doc No: 2014-04679]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER11-2815-007.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: ATSI submits ministerial revisions to OATT Att H-21B
re formatting in ER11-2815 to be effective 6/1/2011.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5165.
    Comments Due: 5 p.m. ET 3/14/14.

    Docket Numbers: ER12-1179-017.
    Applicants: Southwest Power Pool, Inc.
    Description: Errata Filing and Request for Shortened Comment Period
to FCA Compliance to be effective 3/1/2014.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5181.
    Comments Due: 5 p.m. ET 2/27/14.

    Docket Numbers: ER13-684-000.
    Applicants: NV Energy, Inc.
    Description: OATT Revisions Schedule 4--Refund Report (Schedules 4,
9 & 10) to be effective N/A.
    Filed Date: 2/24/14.
    Accession Number: 20140224-5084.
    Comments Due: 5 p.m. ET 3/17/14.

    Docket Numbers: ER14-81-002.
    Applicants: Pacific Gas and Electric Company.
    Description: Updated Effective Date for Balancing Account Revisions
2014 to be effective 5/1/2014.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5166.
    Comments Due: 5 p.m. ET 3/14/14.

    Docket Numbers: ER14-424-001.
    Applicants: Pennsylvania Electric Company, PJM Interconnection,
L.L.C.
    Description: PJM, Penelec & West Penn submit Compliance per 12/4/
2013 Order in ER14-424 to be effective 2/12/2014.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5180.
    Comments Due: 5 p.m. ET 3/14/14.

    Docket Numbers: ER14-455-001.
    Applicants: Green Valley Hydro, LLC, PJM Interconnection, L.L.C.
    Description: PJM & Green Valley Hydro submit Compliance per 12/6/
2013 Order in ER14-455 to be effective 2/12/2014.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5178.
    Comments Due: 5 p.m. ET 3/14/14.

    Docket Numbers: ER14-1353-000.
    Applicants: Puget Sound Energy, Inc.
    Description: Order No 792 Compliance Filing to be effective 2/21/
2014.
    Filed Date: 2/21/14.
    Accession Number: 20140221-5167.
    Comments Due: 5 p.m. ET 3/14/14.

    Docket Numbers: ER14-1354-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Original Service Agreement No. 3739 and Cancellation
of SA No. 3332 to be effective 1/13/2014.
    Filed Date: 2/24/14.
    Accession Number: 20140224-5100.
    Comments Due: 5 p.m. ET 3/17/14.

    Docket Numbers: ER14-1355-000.
    Applicants: Lakeswind Power Partners, LLC.
    Description: Change in Category Status to be effective 2/25/2014.
    Filed Date: 2/24/14.
    Accession Number: 20140224-5112.
    Comments Due: 5 p.m. ET 3/17/14.

    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: February 24, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-04679 Filed 3-3-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14642-14643]
[FR Doc No: 2018-06926]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2002-D-0093]

Liposome Drug Products: Chemistry, Manufacturing, and Controls;
Human Pharmacokinetics and Bioavailability; and Labeling Documentation;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Liposome Drug
Products: Chemistry, Manufacturing, and Controls; Human
Pharmacokinetics and Bioavailability; and Labeling Documentation.''
This guidance document finalizes the revised draft of the same name
that published on October 30, 2015. This guidance provides
recommendations to applicants on the chemistry, manufacturing, and
controls (CMC); pharmacokinetics and bioavailability; and labeling
documentation for liposome drug products submitted in new drug
applications (NDAs) and abbreviated new drug applications (ANDAs),
reviewed by the Center for Drug Evaluation and Research (CDER).

DATES: The announcement of the guidance is published in the Federal
Register on April 5, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2002-D-0093 (formerly 2002D-0337) for ``Liposome Drug Products:
Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and
Bioavailability; and Labeling Documentation.'' 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 this 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. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Richard T. Lostritto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4132, Silver Spring, MD 20993-0002, 301-
796-1697.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Liposome Drug Products: Chemistry, Manufacturing, and
Controls; Human Pharmacokinetics and Bioavailability; and Labeling
Documentation.'' This guidance provides recommendations to applicants
on the CMC, human pharmacokinetics and bioavailability, and labeling
documentation for liposome drug products submitted in NDAs and ANDAs
reviewed by CDER. Although this guidance does not intend to provide
recommendations specific to liposome drug products to be marketed under
biologics license applications (BLAs), many scientific principles
described in this guidance may also apply to these products.
    In the Federal Register of August 21, 2002 (67 FR 54220), FDA
announced the availability of a draft version of this guidance. FDA
published a revised draft guidance on October 30, 2015 (80 FR 66906),
because of the need to address changes in technology since the draft
was first published in 2002, and to add ANDAs to the scope. Most of the
changes to the 2015 revised draft guidance were made to clarify
statements in the 2002 draft guidance. FDA received comments in
response to the draft and revised draft guidance, and this guidance
reflects FDA's careful consideration of those comments.
    The guidance does not provide recommendations on clinical efficacy
and safety studies, nonclinical pharmacology and/or toxicology studies,
liposome formulations of vaccine adjuvants or biologics, or drug-lipid
complexes.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Liposome Drug Products: Chemistry,
Manufacturing, and Controls; Human Pharmacokinetics and
Bioavailability; and Labeling Documentation.'' 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. The Paperwork Reduction Act of 1995

    This 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 in 21 CFR part 314 have been
approved under OMB control number 0910-0001.

III. Electronic Access

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

    Dated: March 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06926 Filed 4-4-18; 8:45 am]
 BILLING CODE 4164-01-P