Introduction: The U.S. Environmental Protection Agency (EPA) will invite selected interested parties to submit this application for Water Infrastructure Finance and Innovation Act (WIFIA) credit assistance. EPA will only select those projects that it expects to proceed to closing. EPA will use the collected information to further evaluate recipients and to develop loan agreement documents. EPA may ask applicants to provide additional supporting materials or to clarify details during the review and negotiating process. The applicant is required to notify of and submit to EPA any superseded application materials during the review period. Unsolicited applications will not be considered.
___________________________________________________________________________________

Purpose: Applicants complete these application materials to provide EPA with information to assess the creditworthiness of the applicant and project, identify the project's engineering and financial risk, negotiate the terms and conditions of the credit assistance, and to calculate the amount of budget authority that will be needed to fund the project(s).
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Format: Applications must include all requested information. Applications should be placed in three-hole punch binders with sections and tabs following the sequence in the application checklist appearing on page four (4) of this application. All narrative information shall not exceed the page limits shown in the application checklist of this application. Narrative information on singled-spaced, standard-sized 8 (1/2)" x 11" pages. Page margins should not be less than 1-inch. Font size should not be smaller than 11 point Times New Roman.
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Submission: Applicants should submit completed applications that include all components on the application checklist.  An applicant should contact the EPA origination team at [EMAIL] if it believes that a requirement is not applicable to its project or it anticipates a delay in one or more source documents. EPA may request additional items from applicants on a case-by-case basis. The completed application packages, including both hard copy and electronic files, should be sent to the attention of NAME, ADDRESS. Applicants must provide electronic files of the entire application and all exhibits on a USB drive or CD.  Exhibits IX, X, and XI must be provided as editable electronic files, not in PDF or "values" format. Applicants are advised to use an express mail or courier delivery service to ensure delivery confirmation of the package. Upon receipt, EPA will provide a confirmation email.
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Selection: EPA's invitation of an interested party to submit an application for the WIFIA program does not imply that EPA has approved all elements proposed in the letter of interest. However, EPA will only select those projects that it expects to proceed to closing. For example, EPA may require changes in the project's financial plan proposed in the letter of interest. Credit assistance is subject to a determination of creditworthiness and negotiation of a credit agreement satisfactory to EPA.
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Charges: EPA requires a non-refundable application fee of [$XX,XXX] for small communities (not more than 25,000 people) and [$XXX,XXX] for all other communities to be paid at the time of submission. A credit processing fee will be charged at the time of closing to pay for the remaining portion of the Agency's cost of retaining expert firms, including legal, engineering, and financial advisory services. EPA will only select those projects that it expects to proceed to closing to be invited into the application phase. If the credit agreement is not executed, the applicant must reimburse EPA for costs incurred in negotiating the credit agreement. The initial application fee will be credited to the credit processing fee. By submitting this application, the applicant certifies that it will pay all required fees as outlined at www.epa.gov/wifia.
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Information Requests: If an applicant desires that any information submitted in its application or any supplement thereto not be released by EPA upon request from a member of the public or otherwise made publicly available, the applicant must identify the confidential business information and provide reasons  why such information is confidential business information and should not be released, including particulars as to any competitive harm which would potentially result from the release of such information. EPA will keep such information confidential to the extent permitted by law.
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Burden: The public reporting and recordkeeping burden for this collection of information is estimated to average 100 hours per response.  Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, included through the use of automated collection techniques to the Director, Regulatory Support Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.
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Warning: Falsification or misrepresentation of information or failure to file or report information required to be reported may be the basis for denial of financial assistance by the Environmental Protection Agency. Knowing and willful falsification of information required to be submitted and false statements to a Federal Agency may also subject you to criminal prosecution.  See, for example, 18 U.S.C. §1001.
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Key Definitions

 Administrator means the Administrator of EPA.

 Applicant means the entity submitting the application for WIFIA credit assistance. Only interested parties that are invited to submit a WIFIA application become applicants. The following entities are eligible to receive credit assistance: a corporation, a partnership, a joint venture, a trust, a Federal, State, or local government, a tribal government or consortium of tribal governments, and a State infrastructure financing authority.

 Community water system has the meaning given the term in section 1401 of the Safe Drinking Water Act (42 U.S.C. 300f).

 Credit assistance means a secured loan or loan guarantee under WIFIA.

 Credit agreement means a contractual agreement between the EPA and the project sponsor (and the lender, if applicable) that formalizes the terms and conditions established in the term sheet (or conditional term sheet) and authorizes the execution of a secured loan or loan guarantee.

 Eligible project costs mean amounts, substantially all of which are paid by, or for the account of, an obligor in connection with a project, including the cost of:
 Development-phase activities, including planning, feasibility analysis (including any related analysis necessary to carry out an eligible project), revenue forecasting, environmental review, permitting, preliminary engineering and design work, and other preconstruction activities;
 Construction, reconstruction, rehabilitation, and replacement activities;
 The acquisition of real property or an interest in real property (including water rights, land relating to the project, and improvements to land), environmental mitigation (including acquisitions pursuant to section 5026(7)), construction contingencies, and acquisition of equipment; and
 Capitalized interest necessary to meet market requirements, reasonably required reserve funds, capital issuance expenses, and other carrying costs during construction.

 Federal credit instrument means a secured loan or loan guarantee authorized to be made available under WFIA with respect to a project.

 Interested party, for the purposes of this part, means an entity submitting a request for WIFIA credit assistance. The following entities are eligible to receive credit assistance: a corporation, a partnership, a joint venture, a trust, a Federal, State, or local government, a tribal government or consortium of tribal governments, and a State infrastructure financing authority. Interested parties become applicants when they are invited to apply for WIFIA credit assistance.

 Investment-grade rating means a rating category of BBB minus, Baa3, bbb minus, BBB (low), or higher assigned by a nationally recognized statistical rating organization (NRSRO) to project obligations.

 Iron and steel products means the following products made primarily of iron or steel: lined or unlined pipes and fittings, manhole covers and other municipal castings, hydrants, tanks, flanges, pipe clamps and restraints, valves, structural steel, reinforced precast concrete, and construction materials.

 Nationally Recognized Statistical Rating Organization (NRSRO) means a credit rating agency identified and registered by the Office of Credit Ratings in the Securities and Exchange Commission.

 Obligor means a party primarily liable for payment of the principal of or interest on a Federal credit instrument, which party may be a corporation; partnership; joint venture; trust; Federal, State, or local governmental entity, agency, or instrumentality; tribal government or consortium of tribal governments. Generally, the obligor is the same as the interested party but is not required to be.

 Project means:
 1 or more activities that are eligible for assistance under section 603(c) of the Federal Water Pollution Control Act (33 U.S.C. 1383(c)), notwithstanding the public ownership requirement under paragraph (1) of that subsection [link].
 1 or more activities described in section 1452(a)(2) of the Safe Drinking Water Act (42 U.S.C. 300j - 12(a)(2)) [link].
 A project for enhanced energy efficiency in the operation of a public water system or a publicly owned treatment works.
 A project for repair, rehabilitation, or replacement of a treatment works, community water system, or aging water distribution or waste collection facility (including a facility that serves a population or community of an Indian reservation).
 A brackish or sea water desalination project, a managed aquifer recharge project, or a water recycling project.
 Acquisition of real property or an interest in real property --
 If the acquisition is integral to a project described in paragraphs (1) through (5); or
 Pursuant to an existing plan that, in the judgment of the Administrator or the Secretary, as applicable, would mitigate the environmental impacts of water resources infrastructure projects otherwise eligible for assistance under this section.
 A combination of projects, each of which is eligible under paragraph (1) or (2), for which a State infrastructure financing authority submits to the Administrator a single application.
 A combination of projects secured by a common security pledge, each of which is eligible under paragraph (1), (2), (3), (4), (5), or (6), for which an eligible entity, or a combination of eligible entities, submits a single application.

 Public entity means:
 a Federal, State, or local Governmental entity, agency, or instrumentality; or
 a Tribal Government or consortium of Tribal Governments.

 Publicly sponsored means the obligor can demonstrate, to the satisfaction of the Administrator that the interested party has consulted with the affected State, local or Tribal Government in which the project is located, or is otherwise affected by the project, and that such government supports the proposed project.

 Small Community means a community of no more than 25,000 individuals.

 State means any one of the fifty states, the District of Columbia, Puerto Rico, or any other territory or possession of the United States.

 State infrastructure financing authority means the State entity established or designated by the Governor of a State to receive a capitalization grant provided by, or otherwise carry out the requirements of, title VI of the Federal Water Pollution Control Act (33 U.S.C. 1381 et. seq.) or section 1452 of the Safe Drinking Water Act (42 U.S.C. 300j - 12).

 Term sheet means a contractual agreement between the EPA and the project sponsor (and the lender, if applicable) that sets forth the key business terms and conditions of a Federal credit instrument. Execution of this document represents a legal obligation of budget authority.

 Treatment works has the meaning given the term in section 212 of the Federal Water Pollution Control Act (33 U.S.C. 1292).

 WIFIA means the Water Infrastructure Finance and Innovation Act of 2014, Pub. L. 113-121, 33 U.S.C. 3901-3914.

Application Checklist
WIFIA applications must include the following
                                     Item
                        Page Limit (excluding Exhibits)
                            Copies (Plus Original)
Application Form
                                                                              1
                                                                              4
Certifications
                                                                              2
                                                                              4
Section A:  Applicant Information
                                                                             10
                                                                              4
 Background

 Organizational Structure

 Litigation and/or Conflicts
 Financial Condition
 Customer Concentration Analysis

Section B:  Detailed Project Information
                                                                             15
                                                                              4
 Project Description
 Location
 Construction Plans and Specifications

 Estimated Project Cost

 Project Schedule
 Alternatives Analysis
 Bond Engineer's Report
 Environmental Review
 Other Permits and Approval

 Project Management and Compliance Monitoring Plan
 Construction Risks and Mitigation Strategies

Section C: Operation and Maintenance Plan
                                                                              8
                                                                              4
 Operation and Maintenance Plant
 Management Experience

 Operational Risks and Mitigation Strategies

Section D:  Financing Plan
                                                                             15
                                                                              4
 Cash Flow Pro Forma
 Source of Funds

 Dedicated Sources of Income for Repayments

 Available Sources of Security
 Preliminary Rating Letter

 Proposed Terms for WIFIA Assistance

 Financing Restrictions

 Rate

Exhibit I:  Applicant Background

                                                                              1
 Exhibit II:  Organizational Chart

                                                                              1
Exhibit III:  Financial Statements

                                                                              1
Exhibit IV:  Project Map

                                                                              1
Exhibit V:  Construction Plans and Specifications

                                                                              1
Exhibit VI:  Alternatives Analysis

                                                                              1
Exhibit VII:  System Engineer's Report

                                                                              1
Exhibit VIII: Operations and Maintenance Plan

                                                                              1
Exhibit IX:  Cash Flow Pro Forma

                                                                              1
Exhibit X:  Source of Funds

                                                                              1
Exhibit XI:  Projected Revenues

                                                                              1
Exhibit XII:  Preliminary Rating Letter

                                                                              1
Exhibit XIII:  Proposed Terms and Conditions for WIFIA Assistance

                                                                              1
Exhibit XII:  Rate Studies and Rate Schedules

                                                                              1
Other:  Non-refundable Application Fee

Application Form

 Applicant's Legal name: __________________________________________________________
 Project Name: __________________________________________________________________
 Other names under which the applicant does business: _________________________________
 Employer/taxpayer identification number (EIN/TIN): ___________________________________
 Dun and Bradstreet Data Universal Number System (DUNS) number: ______________________
 Department and division name: ____________________________________________________
 Business street address, city, state, zip: ______________________________________________
______________________________________________________________________________
 Mailing street address (if different from above): _______________________________________
______________________________________________________________________________
 Applicant website: _______________________________________________________________

Certifications

 National Environmental Policy Act:  The applicant acknowledges that any project receiving credit assistance under this program must comply with all provisions of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.)
 American Iron and Steel:  The applicant acknowledges that any project receiving credit assistance under this program for the construction, alteration, maintenance, or repair of a project may only use iron and steel products produced in the United States and must comply with all applicable guidance.
 Prevailing Wages:  The applicant acknowledges that all laborers and mechanics employed by contractors or subcontractors on projects receiving credit assistance under this program shall be paid wages at rates not less than those prevailing for the same type of work on similar construction in the immediate locality, as determined by the Secretary of Labor, in accordance with sections 3141-3144, 3146, and 3147 of Title 40 (Davis-Bacon wage rules).
 Credit Ratings:  This applicant has received a preliminary rating opinion letter(s) on the project's senior debt instrument, from one or more rating agencies. These letters or ratings are attached as Exhibit XII.
 Credit Processing Fees:  The undersigned certifies that it will reimburse EPA for its costs incurred in negotiating the credit agreement, irrespective of whether the credit agreement is executed.
 Lobbying:  Section 1352 of Title 31, United States Code provides that none of the funds appropriated by any Act of Congress may be expended by a recipient of a contract, grant, loan, or cooperative agreement to pay any person for influencing or attempting to influence an officer or employee of any Federal agency, a Member of Congress, or an employee of a Member of Congress in connection with the award or making of a Federal contract, grant, loan, or cooperative agreement or the modification thereof. The EPA interprets this provision to include the use of appropriated funds to influence or attempt to influence the selection for assistance under the WIFIA program.
WIFIA applicants must file a declaration: (a) with the submission of an application for WIFIA credit assistance; (b) upon receipt of WIFIA credit assistance (unless the information contained in the declaration accompanying the WIFIA application has not materially changed); and (c) at the end of each calendar quarter in which there occurs any event that materially affects the accuracy of the information contained in any declaration previously filed in connection with the WIFIA credit assistance.
The undersigned certifies, to the best of his or her knowledge and belief, that:
 No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of an agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.
 If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, "Disclosure Form to Report Lobbying," in accordance with its instructions.
 The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans, and cooperative agreements) and that all subrecipients shall certify and disclose accordingly.
         This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by section 1352, title 31, U.S. Code. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.
 Debarment:  The undersigned further certifies that it is not currently, nor has it been in the preceding three years: 1) debarred, suspended, or declared ineligible from participating in any Federal program; 2) formally proposed for debarment, with a final determination still pending; 3) voluntarily excluded from participation in a Federal transaction; or 4) indicted, convicted, or had a civil judgment rendered against it for any of the offenses listed in the Regulations Governing Debarment and Suspension (Governmentwide Nonprocurement Debarment and Suspension Regulations: 2 C.F.R. Part 180 and Part 1532.
 Default/Delinquency:  The undersigned further certifies that neither it nor any of its subsidiaries or affiliates are currently in default or delinquent on any debt or loans provided or guaranteed by the Federal Government.
 Other Federal Requirements:  The applicant acknowledges that it must comply with all other federal statutes and regulations, as applicable.  A non-exhaustive list of federal cross-cutting statutes and regulations can be found at: www.epa.gov/wifia.
 Name:
Title:
Organization:
Street Address:
City/State/Zip:
Phone:
E-mail:

Name:
Title:
Organization:
Street Address:
City/State/Zip:
Phone:
E-mail:

Signature:  By submitting this application, the undersigned certifies that the facts stated and the certifications and representations made in this application are true, to the best of the applicant's knowledge and belief after due inquiry, and that the applicant has not omitted any material facts. The undersigned is an authorized representative of the applicant.Signature:  _________________________________________________________________________
Date Signed: ________________________________________________________________________

Supporting Narrative
Section A: Applicant Information (10 page limit, excluding Exhibits)
 Background:
 Describe the applicant's history, ownership, and legal structure (e.g., state governmental agency, local governmental agency, corporation, or partnership). Include a copy of the statutory authority under which the entity was created as part of Exhibit I, if applicable.
 Describe the legal authority of the applicant to carry out proposed project activities described in the application packet, including levying taxes, issuing debt, charging fees, and/or receiving dedicated funding from another entity. Provide documentation as part of Exhibit I.
 Identify what governmental entities (other than the applicant) approved the submission of this application packet and must approve the funding of activities or the carrying out of activities in the application (other than permits). Provide documentation explaining the approval process as part of Exhibit I.
 Organizational Structure:
 Describe the applicant's organizational structure and the applicant's relationship to any subsidiaries or affiliates. Include the legal names of key principals and staff (e.g., project manager and chief financial officer) and any recent or proposed changes to the organizational structure.
 Provide an organizational chart as Exhibit II, to include the major parties involved in planning, owning, financing, constructing, operating, and/or maintaining the project(s). Include the major service contractors that have been, or will be, retained for the project (e.g., architects, developers, engineers, attorneys, financial advisors and underwriters, environmental consultants). EPA may request additional documentation from major parties other than the applicant as part of the project evaluation and approval process.
 Litigation and/or Conflicts: Disclose any current, threatened, or pending litigation involving the applicant related to permitting, public involvement, environmental irregularities, construction defects, securities fraud, conflict of interest, failure to perform under a State or Federal contract, or other charges which may reflect on the applicant's financial position or ability to complete the project(s).
 Financial Condition: Provide financial documents not previously submitted in the letter of interest as Exhibit III. These may include, as available, year-end audited financial statements for the past three years, Capital Improvement Plans or other planning documents and budgets produced in the last [five] years accompanied by a description of  the budgeting and capital planning process, a description of account receivable outstanding including the 12 month trailing average of on-time payment amounts as a percentage of amount billed per period, and the status of liabilities and funding for defined benefits and other post-employment benefits.
 Customer Concentration Analysis:  List the historical, if available, or projected breakdown of customers by class and revenue. List the top ten customers by percentage of revenues.
Section B: Detailed Project Information (15 page limit, excluding Exhibits)
 Project Description: Describe the need for the project(s), its basic design features, and what it will accomplish. Include an assessment of the current condition of all water facilities relating to the project. If the project(s)'s current scope differs from what is described in the letter of interest, please explain.
 Location: Describe the location of the project(s) and attach a map as Exhibit IV. Include the name(s) of the counties that the project(s) will serve.
 Construction Plans and Specifications: Attach the construction plans and specifications (with P.E. stamp, if available) for the project(s), including, but not limited to, construction drawings, specifications, construction contract forms, bidding instructions, etc., as Exhibit V. For alternative project delivery methods (i.e., design-build, construction manager at-risk, design-bid-build), include contractor selection materials such as Request for Qualifications and Request for Proposals. Draft materials are acceptable for the initial application. However, it is expected that final materials will be available for review and approval prior to the obligation event for the loan.
 Estimated Project Cost:
 Provide a detailed cost estimate for the project(s). Distinguish between total and eligible project costs. Describe any costs or activities that may not be WIFIA-eligible.
 For eligible project costs, provide an activity breakdown, as applicable, for: development-phase activities; construction, reconstruction, rehabilitation, and replacement activities; the acquisition of real property or an interest in real property, environmental mitigation, construction contingencies, and acquisition of equipment; and capitalized interest, reasonably required reserve funds, capital issuance expenses, and other carrying costs during construction. Include other cost categories as necessary.
 Project Schedule(s): Provide a timeline(s) that illustrates the estimated start and completion dates for each major phase or milestone of project development, construction, and/or acquisition. Indicate the applicant's current status on this timeline.
 Alternatives Analysis:
 If an alternatives analysis or business case analyses was not provided in the letter of interest, provide documentation of such analysis.
 Describe in detail the alternatives available, including the discussion of a "no action" alternative. The number and types of alternatives depend upon the scope and complexity of the project.
 Use a minimum planning period of five (5) years, and a maximum planning period not to exceed the useful life of the project.
 Describe the rationale (i.e., lowest capital cost, greater ease of operation, most reliable, fewest environmental impacts, etc.) for the selected alternative. This rationale should include the technical, managerial, financial, environmental, operational, and local decision making approaches.
 Provide any referenced documents as Exhibit VI.
 System Engineer's Report(s):  If available, and developed within the past five years, provide the independent engineer's report(s), bond engineer's report(s), system master plan(s), or any other like document(s).  Summarize the primary conclusions of the report(s) and indicate how the proposed project(s) fits into the long term planning of the system. Include any applicable report(s) as Exhibit VII.
 Environmental Review: Summarize the status of the project(s)'s environmental review. Specifically, discuss whether the project(s) has received a Categorical Exclusion, Finding of No Significant Impact, or Record of Decision, or at a minimum, whether a draft Environmental Impact Statement has been circulated in accordance with the National Environmental Policy Act. A copy of the report(s) will be required prior to execution of the credit agreement with EPA.
 Other Permits and Approval: List all other major permits and approvals necessary for construction of the project(s) and the date, or projected date, of the applicant's receipt of such permits and approvals. The list should include permits and approvals required under local, regional, State, and Federal laws and regulations. In particular, indicate when outstanding approvals by State or local government entities are expected. Copies of major permits and approvals will be required upon execution of a credit agreement with EPA.
 Project Management and Compliance Monitoring Plan:  Provide a comprehensive project management and monitoring plan that will demonstrate the applicant's ability to deliver the project(s) as planned, fulfill all project commitments, and ensure compliance with all terms of the credit agreement, including all applicable regulations and provision of law. The plan should provide: (a) information on the roles and responsibilities of all entities with decision making authority for the project(s); (b) status reporting processes that document not only the status but changes and potential risks; and (c) coordination processes that provide for advance notification of potential issues to all appropriate agencies and timely resolution.
 Risks and Mitigation Strategies:  Identify risks to the project completion and sufficiency of revenues. Sample risks might include construction schedules, cost escalation, approvals, and litigation. Identify any mitigation strategies and proposed cost-containment approaches (e.g., design-build, value engineering, guaranteed maximum price and/or completion date, warranties, or other incentive/disincentive clauses).

Section C: Operations and Maintenance Plan (8 page limit, excluding Exhibits)
 Operation and Maintenance Plan: Attach the operation and maintenance plan for the project(s) as Exhibit VIII. This plan should describe any contractual arrangements that the applicant plans to execute for the operation and maintenance of the project(s), cost estimates for operating and maintaining the project(s), key performance indicators, insurance policies that may be used to cover the project(s), and reserves that will be set aside for the maintenance of the project(s). Draft materials are acceptable for the initial application. However, it is expected that final materials will be available for review and approval prior to the obligation event for the loan.
 Management Experience:  Describe each contractor with whom the project(s) has a contractual arrangement for the operation and maintenance of the project(s), or the management team that will be overseeing the operation and maintenance of the project(s). This description should list the members of the management team, and similar projects that each member of the management team has worked on.
 Operational Risks and Mitigation Strategies:  Identify operational risks facing the project(s), such as insufficient subscription, insufficiency of supply, deterioration of distribution and conveyance systems, and litigation risks. Identify all mitigation strategies.
Section D: Financing Plan (15 page limit, excluding Exhibits)
 Cash Flow Pro Forma: Attach the cash flow pro forma(s) for the project(s) as Exhibit IX. The pro forma(s) should include both a statement of sources and uses and a projection of monthly or quarterly cash flows during the construction period and annual cash flows thereafter. All amounts should be expressed on a cash (year-of-expenditure) basis and should include a narrative describing assumptions used to arrive at such estimates.  The pro forma(s) should include:
 Projected cash flows through such time as all project debt is repaid, including separate line items for each category of revenue (such as taxes and user fees) and expenditure (at a minimum, construction expenditures, operations and maintenance, contributions to reserves and capital replacement funds, debt service, repayments of the WIFIA credit assistance, and repayment of other borrowed funds, if any);
 Estimated debt service coverage, separated into Federal, non-Federal (addressing, as applicable, senior and junior lien debt), and illustrating projected combined coverage, as applicable;
 Amortization schedule for all project debt, separated into Federal, non-Federal (addressing, as applicable, senior- and junior-lien debt), and combined components; and
 Anticipated repayment schedule illustrating the disbursement and repayment of the requested WIFIA credit assistance.
 Sources of Funds:
 List the source of funds for the total project(s). Sources should include separate line items, as applicable, for Federal grants, State grants, local grants, private investment (equity or debt); any other contributions, market value of right-of-way dedications, bond proceeds (general obligation, revenue, and others), other borrowing (specify), investment income, revenues, and Federal credit assistance proceeds. For each line item, describe the status of the source (e.g., requested, committed, and received).  Provide supporting documentation to evidence the status of these funds in Exhibit X.
 List all the uses of funds for the total project(s). Uses should include separate line items, as applicable, for development-phase activities; construction, reconstruction, rehabilitation, and replacement activities; the acquisition of real property or an interest in real property, environmental mitigation, construction contingencies, and acquisition of equipment; and capitalized interest. Include other uses categories as necessary.
   Note:  Total sources and uses should be equal to one another and equal the estimated total project costs. All estimates should be expressed in year-of-expenditure dollars.
 Dedicated Sources of Income for Repayment:
 Describe all revenue sources to be used to repay project financing. Specify the nature of the revenue source (dedicated or not dedicated), the expected rate(s), the base to which such rates will be applied (e.g. average monthly consumption), projected revenues from each source, and projected increases or decreases in such revenues over time. Include rate covenants that may affect these revenue sources.
 Elaborate on existing or anticipated pledges/claims on revenues and provide a brief summary of all claims on the flow of funds
 Attach documentation as Exhibit XI to provide the basis for projected revenues and their respective anticipated rates of change. If independent revenue projections have not yet been obtained, state when such independent projections will be completed and identify the consultant engaged to perform the analysis.
 Available Sources of Security:  Describe any source of revenues or assets that the applicant(s) plans to use as security for the WIFIA assistance.
 Preliminary Rating Letter from a Rating Agency on the Project's Senior Obligations:  Submit as Exhibit XII a preliminary rating letter from a rating agency, describing the applicant's ability to obtain an investment grade rating on the project(s)'s senior obligation(s), which may be the WIFIA assistance.
 Proposed Terms for the WIFIA assistance: Identify the proposed terms for the requested WIFIA credit assistance, including at a minimum the amount, origination date, final maturity date, estimated interest rate, timing of disbursements, pledged security, repayment sources, amortization schedule, and lien position. The proposed terms and conditions should be submitted as Exhibit XIII.
 Financing Restrictions:  Describe any restrictions that may limit the project(s)'s ability to pursue additional funding or transfer funds from the applicant, such as Additional Bonds Tests or closed indentures.
 Rate:  Describe any regulations governing rate setting, including rate covenants. If applicable, include rate studies and rate schedules for the applicant from the last ten years as Exhibit XIV. Additionally, include historical rate changes for at least five and preferably ten years.


[Federal Register Volume 82, Number 196 (Thursday, October 12, 2017)]
[Notices]
[Page 47503]
[FR Doc No: 2017-22000]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP17-80-000]

Notice of Schedule for Environmental Review of the Eastern
Panhandle Expansion Project; Columbia Gas Transmission, LLC

    On March 15, 2017, Columbia Gas Transmission, LLC (Columbia) filed
an application in Docket No. CP17-80-000 requesting a Certificate of
Public Convenience and Necessity pursuant to Section 7(c) of the
Natural Gas Act to construct and operate certain natural gas pipeline
facilities. The proposed project is known as the Eastern Panhandle
Expansion Project (Project), and would involve construction and
operation of approximately 3.4 miles of 8-inch-diameter pipeline in
Fulton County, Pennsylvania; Washington County, Maryland: and Morgan
County, West Virginia.
    On April 25, 2017, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--January 26, 2018
90-day Federal Authorization Decision Deadline--April 26, 2018

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    Columbia proposes to construct, operate, and maintain the Project
in three counties and states (Fulton County, Pennsylvania; Washington
County, Maryland; and Morgan County, West Virginia). The Project would
provide an additional 47.5 dekatherms per day (Dth/d) of capacity for
firm transportation service to markets in West Virginia through
Mountaineer Gas Company's (Mountaineer) gathering system. The Project
will involve the construction and operation of approximately 3.4 miles
of new greenfield 8-inch-diameter pipeline, three main line valves, and
two new tie-in assemblies.

Background

    On April 25, 2017, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Eastern Panhandle
Expansion Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. In response to the NOI, the Commission
received comments from: the U.S. Army Corps of Engineers, the U.S.
Department of Interior, National Park Service, Potomac Riverkeeper
Network, Upper Potomac Riverkeeper, Waterkeepers Chesapeake, Allegheny
Defense Project, West Virginia Rivers, 1,761 signatories from the
Chesapeake Climate Action Network, and 115 concerned citizens from the
region. The primary issues raised by the commentors are: Potential
impacts on the Potomac River, karst features, groundwater quality,
safety, climate change, and the Chesapeake and Ohio Canal National
Historical Park.
    The U.S. Department of Interior, National Park Service and the U.S.
Environmental Protection Agency are cooperating agencies in the
preparation of the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC Web site (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP17-080), and follow the
instructions. For assistance with access to eLibrary, the helpline can
be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC Web site also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: October 5, 2017.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2017-22000 Filed 10-11-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Rules and Regulations]
[Page 13678]
[DOCID:fr23mr10-11]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 3

[Docket No. FDA-2010-N-0010]

Product Jurisdiction; Change of Address and Telephone Number;
Technical Amendment

Agency: Food and Drug Administration, HHS.

Action: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to reflect a change in the address and telephone number for
the Office of Combination Products (OCP). This action is editorial in
nature and is intended to improve the accuracy of the agency's
regulations.

DATES: Effective Date: April 19, 2010.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 5130, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
To confirm that this change of address and telephone number has
occurred, please see our Web site at www.fda.gov/CombinationProducts/
default.htm.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
part 3 to reflect a change in the address and telephone number for OCP.
Publication of this document constitutes final action on this change
under the Administrative Procedure Act (5 U.S.C. 553). Notice and
public procedures are unnecessary because FDA is merely updating
nonsubstantive content.

List of Subjects in 21 CFR Part 3

    Administrative practice and procedure, Biologics, Combination
products, Drugs, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
3 is amended as follows:

PART 3--PRODUCT JURISDICTION

0
1. The authority citation for 21 CFR part 3 continues to read as
follows:

    Authority: 21 U.S.C. 321, 351, 353, 355, 360, 360c-360f, 360h-
360j, 360gg-360ss, 360bbb-2, 371(a), 379e, 381, 394; 42 U.S.C. 216,
262, 264.

Sec.  3.6  [Amended]

0
2. Section 3.6 is amended by removing ``(HFG-3), Food and Drug
Administration, 15800 Crabbs Branch Way, suite 200, Rockville, MD
20855,<PHONE_NUMBER>''and by adding in its place ``Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>,''.

    Dated: March 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6246 Filed 3-22-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register: September 21, 2010 (Volume 75, Number 182)]
[Rules and Regulations]
[Page 57371-57373]
[DOCID:fr21se10-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0710; Directorate Identifier 2010-NE-26-AD;
Amendment 39-16434; AD 2010-19-06]
RIN 2120-AA64

Airworthiness Directives; Turbomeca Arriel 1 Series Turboshaft
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    Metallurgical non-conformities have been found when performing
quality inspections during production of Arriel 1 gas generator (GG)
second stage turbine discs introduced by Turbomeca Modification
TU347 (P/N 0 292 25 040 0). Analysis has concluded that the approved
life limit of the post-TU347 GG second stage turbine disc needs to
be reduced to 2,500 GG cycles.

We are issuing this AD to prevent failure of the gas generator second
stage turbine disc which could result in the release of high energy
debris and damage to the helicopter.

DATES: This AD becomes effective October 6, 2010.
    We must receive comments on this AD by October 21, 2010.
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC
20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Richard Woldan, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, previously
issued EASA AD 2010-0101-E, dated June 4, 2010, and has now issued a
revision to that AD, which is AD 2010-0101R1, dated August 4, 2010
(referred to after this as ``the MCAI''), to correct an unsafe
condition for the specified products. The MCAI states:

    Metallurgical non-conformities have been found when performing
quality inspections during production of Arriel 1 gas generator (GG)
second stage turbine discs introduced by Turbomeca Modification
TU347 (P/N 0 292 25 040 0). Analysis has concluded that the approved
life limit of the post-TU347 GG second stage turbine disc needs to
be reduced to 2,500 GG cycles.
    Since issuance of AD 2010-0101-E, Turbomeca has introduced a
reinforced Eddy-current inspection which provides a lower (improved)
detection threshold of the metallurgical non-conformities. This
reinforced Eddy-current inspection, named ``CFR'', combined with a
revised analysis, allows to increase the life limit of the post-
TU347 GG second Stage Turbine Discs identified as ``CFR'' over the
2,500 GG life cycles of the ``non-CFR'' Discs.

You may obtain further information by examining the MCAI in the AD
docket.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of France,
and is approved for operation in the United States. Pursuant to our
bilateral agreement with France, they have notified us of the unsafe
condition described in the MCAI and service information referenced
above. We are issuing this AD because we evaluated all information
provided by EASA and determined the unsafe condition exists and is
likely to exist or develop on other products of the same type design.
This AD requires:
     For gas generator second stage turbine discs, part number
(P/N) 0 292 25 040 0 that do not have the ``CFR'' marking, removing
them from service before exceeding 2,500 cycles-in-service (CIS) since-
new or within 20 CIS from the effective date of the AD, whichever
occurs later; and
     For gas generator second stage turbine discs, P/N 0 292 25
040 0 that have the ``CFR'' marking, removing them from service before
exceeding 3,500 CIS since-new.

Differences Between the AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. This AD differs from the MCAI and/
or service information as follows:
     EASA AD 2010-0101R1, dated August 4, 2010, requires second
stage turbine discs with fewer than 2,500 CIS to be removed upon
accumulating 2,500 CIS.
     EASA AD 2010-0101R1, dated August 4, 2010, requires
revising the approved aircraft maintenance program to reflect the life
limit of 2,500 CIS.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the short compliance

time in removing affected gas generator second stage discs that are
near or over the reduced life limit. Therefore, we determined that
notice and opportunity for public comment before issuing this AD are
impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2010-0710; Directorate
Identifier 2010-NE-26-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this AD. Using the search function of the
Web site, anyone can find and read the comments in any of our dockets,
including, if provided, the name of the individual who sent the comment
(or signed the comment on behalf of an association, business, labor
union, etc.). You may review the DOT's complete Privacy Act Statement
in the Federal Register published on April 11, 2000 (65 FR 19477-78).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2010-19-06 Turbomeca: Amendment 39-16434.; Docket No. FAA-2010-0710;
Directorate Identifier 2010-NE-26-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective October
6, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Turbomeca Arriel 1A, 1A1, 1B, 1C, 1C1,
1C2, 1D, 1D1, and 1S1 turboshaft engines that have incorporated
Modification TU347. These engines are installed on, but not limited
to, Eurocopter AS350 series, AS365 and SA365 series, Sikorsky S-76A
series and S-76C series helicopters.

Reason

    (d) Metallurgical non-conformities have been found when
performing quality inspections during production of Arriel 1 gas
generator (GG) second stage turbine discs introduced by Turbomeca
Modification TU347 (P/N 0 292 25 040 0). Analysis has concluded that
the approved life limit of the post-TU347 GG second stage turbine
disc needs to be reduced to 2,500 GG cycles.

We are issuing this AD to prevent failure of the gas generator
second stage turbine disc which could result in the release of high
energy debris and damage to the helicopter.

Actions and Compliance

    (e) Unless already done, do the following:
    (1) For gas generator second stage turbine discs, part number
(P/N) 0 292 25 040 0 that do not have the ``CFR'' marking, remove
from service before exceeding 2,500 cycles-in-service (CIS) since-
new or within 20 CIS from the effective date of this AD, whichever
occurs later.
    (2) For gas generator second stage turbine discs, P/N 0 292 25
040 0 that have the ``CFR'' marking, remove from service before
exceeding 3,500 CIS since-new.

Gas Generator Second Stage Turbine Installation Prohibition

    (3) After the effective date of this AD, for gas generator
second stage turbine discs, P/N 0 292 25 040 0 that do not have the
``CFR'' marking, and have 2,500 or more CIS since-new, do not
install into any engine.
    (4) After the effective date of this AD, for gas generator
second stage turbine discs, P/N 0 292 25 040 0 that have the ``CFR''
marking, and have 3,500 or more CIS since-new, do not install into
any engine.

FAA AD Differences

    (f) This AD differs from the Mandatory Continuing Airworthiness
Information (MCAI) and/or service information as follows:
    (1) European Aviation Safety Agency (EASA) AD 2010-0101R1, dated
August 4, 2010, requires second stage turbine discs with fewer than
2,500 CIS to be removed upon accumulating 2,500 CIS.
    (2) EASA AD 2010-0101R1, dated August 4, 2010, requires revising
the approved aircraft maintenance program to reflect the new reduced
life limit of 2,500 CIS.

Alternative Methods of Compliance (AMOCs)

    (g) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (h) Refer to EASA AD 2010-0101R1, dated August 4, 2010, and
Turbomeca Alert Mandatory Service Bulletin No. A292 72 0831, Version
B, dated July 7, 2010, for related information. Contact Turbomeca,
40220 Tarnos, France; telephone 33 05 59 74 40 00, fax 33 05 59 74
45 15, for a copy of this service information.
    (i) Contact Richard Woldan, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New

England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781) 238-
7199, for more information about this AD.

Material Incorporated by Reference

    (j) None.

    Issued in Burlington, Massachusetts, on September 10, 2010.
Francis A. Favara,
Manager, Engine and Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2010-23100 Filed 9-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 182 (Thursday, September 23, 2021)]
[Notices]
[Pages 52911-52912]
[FR Doc No: 2021-20514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0399]

Good Manufacturing Practices for Animal Cells, Tissues, and Cell-
and Tissue-Based Products; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry #253
entitled ``Good Manufacturing Practices for Animal Cells, Tissues, and
Cell- and Tissue-Based Products.'' FDA's Center for Veterinary Medicine
(CVM) is issuing this guidance to provide establishments that
manufacture animal cells, tissues, and cell- and tissue-based products
(ACTPs) meeting the definition of new animal drugs with recommendations
for meeting requirements for current good manufacturing practices
(CGMPs). All new animal drugs, including ACTPs, are required to be
manufactured in accordance with CGMPS to ensure that such drugs meet
the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
as to safety, and have the identity, strength, quality, and purity
characteristics, which they purport to or are represented to possess.
This guidance also provides FDA's recommendations for those aspects of
manufacturing specific to ACTPs in accordance with existing CGMP
regulations, as applicable, and with the FD&C Act. In this guidance, we
specifically address the methods, facilities, and controls used for
manufacturing ACTPs.

DATES: Submit either electronic or written comments on the draft
guidance by November 22, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0399 for ``Good Manufacturing Practices for Animal Cells,
Tissues, and Cell- and Tissue-Based Products.''

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,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lynne Boxer, Center for Veterinary
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
(GFI) #253 entitled ``Good Manufacturing Practices for Animal Cells,
Tissues, and Cell- and Tissue-Based Products.'' CVM is issuing this
guidance to provide establishments that manufacture ACTPs with
recommendations for meeting CGMP requirements. All new animal drugs,
including ACTPs, are required to be manufactured in accordance with
CGMPS to ensure that such drugs meet the requirements of the FD&C Act
as to safety and have the identity, strength, quality, and purity
characteristics that they purport to or are represented to possess. The
CGMP requirements for new animal drugs are found in Title 21 parts 210
and 211 of the Code of Federal Regulations (parts 210 and 211 (21 CFR
parts 210 and 211)). The CGMP regulations in parts 210 and 211 are
broad in scope, and we recognize that these regulations do not
specifically or fully address all aspects of the manufacture of ACTPs,
including early stages of the manufacturing process. This guidance
provides our recommendations for complying with section 501(a)(2)(B) of
the FD&C Act (21 U.S.C. 351(a)(2)(B)) for those aspects of
manufacturing specific to ACTPs.
    ACTPs that meet the definition of a new animal drug are subject to
the same statutory and regulatory requirements found under the FD&C Act
and Title 21 of the CFR. Sponsors are responsible for ensuring that
their products are manufactured in accordance with Federal law,
including parts 210 and 211 and section 501(a)(2)(B) of the FD&C Act.
New animal drugs not manufactured in conformity with CGMPs are
adulterated under the relevant provisions of the FD&C Act.
    This guidance specifically addresses the methods, facilities, and
controls used for manufacturing ACTPs, including steps in recovery,
processing, storage, labeling, packaging, and distribution. We refer to
our recommendations for meeting CGMPs in the manufacture of ACTPs as
ACTP CGMPs. These ACTP CGMPs should be applied to consistently produce
quality and to ensure that ACTPs are not contaminated and do not become
contaminated during manufacturing.
    This level 1 draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of FDA on good
manufacturing practices for animal cells, tissues, and cell- and
tissue-based products. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, http://inside.fda.gov:9003/PolicyProcedures/GuidanceRegulations/FederalRegister/default.htm, or https://www.regulations.gov.

    Dated: September 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20514 Filed 9-22-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 167 (Monday, August 29, 2011)]
[Notices]
[Page 53702]
[FR Doc No: 2011-22069]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on August 31, 2011 at
10 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
    Item 1: The Commission will consider whether to issue a concept
release and request public comment on a wide range of issues under the
Investment Company Act raised by the use of derivatives by investment
companies regulated under that Act.
    Item 2: The Commission will consider whether to issue two related
releases. The first release is an advance notice of proposed rulemaking
to solicit public comment on possible amendments to Rule 3a-7 under the
Investment Company Act, the rule that provides certain asset-backed
issuers with a conditional exclusion from the definition of investment
company. The second release is a concept release to solicit public
comment on interpretive issues related to the status under the
Investment Company Act of companies that are engaged in the business of
acquiring mortgages and mortgage-related instruments.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact:
    The Office of the Secretary at<PHONE_NUMBER>.

    Dated: August 24, 2011.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2011-22069 Filed 8-25-11; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22517-22518]
[FR Doc No: 2015-09238]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OEI-2006-0037; FRL-9925-28-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Exchange Network Grants Progress Reports
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``Exchange Network Grants
Progress Reports (Renewal)'' (EPA ICR No. 2207.06, OMB Control No.
2025-0006) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a proposed extension of the ICR, which is currently
approved through April 30, 2015. Public comments were previously
requested via the Federal Register (80 FR 2099) on January 15, 2015
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before May 22, 2015.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OEI-2006-0037, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Michael Kaufman, Information Exchange
and Services Division, Office of Information Collection (2823T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-1684; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This notice announces the collection of information
related to the U.S. EPA National Environmental Information Exchange
Network (NEIEN) Grant Program. EPA proposes to collect information from
the NEIEN grantees on assistance agreements EPA has awarded.
Specifically, for each project, EPA proposes to have grantees submit
semi-annual reports on the progress and current status of each goal and
output, completion dates for outputs, and any problems encountered.
This information will help EPA ensure projects are on schedule to meet
their goals and produce high quality environmental outputs. New award
recipients will complete one Quality Assurance Reporting Form for each
award. This form provides a simple means for grant recipients to
describe how quality will be addressed throughout their projects.
Additionally, the Quality Assurance Reporting Form is derived from
guidelines provided in the NEIEN 2011 Grant Solicitation Notice.
    Form Numbers: EPA Form 5300-26 (Semi-Annual Progress Report Form)
and EPA Form 5300-27 (Quality Assurance Reporting Form).

    Respondents/affected entities: State, tribal, and territorial
environmental government offices.
    Respondent's obligation to respond: Mandatory (2 CFR part 200 and 2
CFR part 1500).
    Estimated number of respondents: 200 (total).
    Frequency of response: Twice per year for the Semi-Annual Progress
Report Form; one time per grant for the Quality Assurance Reporting
Form.
    Total estimated burden: 340 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $17,979 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 5 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to a decrease in the number of
grants that are awarded annually.

Courtney Kerwin,
Acting Director, Collection Strategies Division.
[FR Doc. 2015-09238 Filed 4-21-15; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 189 (Thursday, September 29, 2016)]
[Notices]
[Pages 66962-66963]
[FR Doc No: 2016-23463]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2016-0204; FRL-9953-31-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Information Collection Effort for Oil and
Gas Facilities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), ``Information Collection Effort
for Oil and Gas Facilities'' (EPA ICR No. 2548.01, OMB Control No.
2060--NEW) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). This is a request for approval of a new collection. Public
comments were previously requested via the Federal Register (81 FR
35763) on June 3, 2016, during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A complete
description of the ICR is provided below, including its estimated
burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before October 31,
2016.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OAR-2016-0204, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW., Washington, DC 20460, and (2) OMB via email
to<EMAIL_ADDRESS>Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Brenda Shine, Sector Policies and
Programs Division (E143-01), Office of Air Quality Planning and
Standards, Environmental Protection Agency, Research Triangle Park, NC
27711; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Collectively, oil and gas facilities are the largest
industrial emitters of methane in the U.S. While a great deal of
information is available on the oil and gas industry and has to date
provided a strong technical foundation to support the Agency's recent
actions, the EPA is now seeking more specific information that would be
of critical use in addressing existing source emissions pursuant to
Clean Air Act (CAA) section 111(d). Taking into account the large
number of sources that a national regulation development effort would
need to consider, and the potential for taking a different approach to
addressing co-located existing sources than was taken with new and
modified sources, the EPA requires information that will enable the
development of effective standards for this entire industry under CAA
section 111(d).
    There will be two parts to the information collection. Part 1,
referred to as the operator survey, is specifically designed to obtain
information from onshore oil and gas production facilities to better
understand the number and types of equipment at production facilities.
Part 2, referred to as the detailed facility survey, will be sent to
selected oil and gas facilities across the different industry segments.
Part 2 will collect detailed, unit-specific information on emission
sources at the facility and any emission control devices or management
practices used to reduce emissions. Due to the large number of
potentially affected facilities, Part 2 uses a statistical sampling
method

considering each industry segment (and groupings of facilities in the
production segment) to be separate sampling populations. Thus, a
statistically significant number of facilities within each industry
segment (or ``population'') will be required to complete the Part 2
detailed facility survey.
    The data collected throughout this process will be used to
determine the number of potentially affected emission sources and the
types and prevalence of emission controls or emission reduction
measures used for these sources at existing oil and gas facilities,
among other purposes. This information may also be used to fill data
gaps, to evaluate the emission and cost impacts of various regulatory
options, and to establish appropriate standards of performance for oil
and gas facilities.
    Respondents will be required to respond under the authority of
section 114 of the CAA. The EPA anticipates issuing the CAA section 114
letters by late October, 2016. These letters would require the owner/
operator of an oil and gas facility to complete and submit the Part 1
survey within 30 days of receipt of the survey, and would require
facilities to complete and submit the Part 2 survey with 120 days of
receipt.
    All information submitted to the Agency in response to the surveys
will be managed in accordance with applicable laws and the EPA's
regulations governing treatment of CBI at 40 CFR part 2, subpart B. Any
information determined to constitute a trade secret will be protected
under 18 U.S.C. 1905.
    Form numbers: None.
    Respondents/affected entities: Respondents affected by this action
are owners/operators of oil and natural gas facilities.
    Respondent's obligation to respond: Mandatory. (Pursuant to section
114 of the CAA.)
    Estimated number of respondents: The estimated number of
respondents for Part 1 is 15,000 operators representing approximately
698,800 facilities (total). The estimated number of respondents for
Part 2 is 3,818.
    Frequency of response: This is a one-time survey.
    Total estimated burden: 245,481 hours. Burden is defined at 5 CFR
1320.03(b).
    Total estimated cost: $37,692,625, which includes $6,987,000 in
operating and maintenance (O&M) costs.
    Changes in estimates: This is a new ICR.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2016-23463 Filed 9-28-16; 8:45 am]
 BILLING CODE 6560-50-P