Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52153 

1The determination was done in compliance with 

NEPA (42 U.S.C. 4321–4347); the Council on 

Environmental Quality Regulations for 

implementing NEPA (40 CFR parts 1500–1508); and 

DOE NEPA Implementing Procedures and 

Guidelines (10 CFR part 1021). 

BILLING CODE 6450–01–C 

C. WAPA’s Consideration of 

Applications 

1. Upon receipt, WAPA will review 

the APD form and verify that each 

applicant meets the general eligibility 

criteria set forth in Section II above. 

a. WAPA will request, in writing, 

additional information from any 

applicant whose APD form is deficient. 

The applicant shall have 15 calendar 

days from the date on WAPA’s request 

letter to provide, in writing, the 

requested information. If the requested 

information is not provided within that 

time period, the application will not be 

considered. 

b. If WAPA determines that an 

applicant does not meet the general 

eligibility criteria, WAPA will send a 

letter explaining why the applicant did 

not qualify. 

c. If an applicant meets the general 

eligibility criteria, WAPA will 

determine the amount of firm power to 

be allocated under the general allocation 

criteria set forth in Section III above. 

WAPA will send for the applicant’s 

review a draft firm electric service 

contract, which contains the terms and 

conditions of the offer and the amount 

of firm power allocated to the applicant. 

2. WAPA reserves the right to 

determine the amount of firm power to 

allocate to an applicant, as justified by 

an applicant’s APD form. 

VI. Regulatory Procedure Requirements 

A. Review Under the National 

Environmental Policy Act (NEPA) 

WAPA has determined this action fits 

within the following categorical 

exclusion listed in appendix B to 

subpart D of 10 CFR part 1021.B4.1 

(Contracts, policies, and marketing and 

allocation plans for electric power). 

Categorically excluded projects and 

activities do not require preparation of 

either an environmental impact 

statement or an environmental 

assessment.1 Specifically, WAPA has 

determined this rulemaking is 

consistent with activities identified in 

part B4, Categorical Exclusions 

Applicable to Specific Agency Actions 

(see 10 CFR part 1021, appendix B to 

subpart D, part B4). A copy of the 

categorical exclusion determination is 

available on WAPA–RMR’s website at: 

https://www.wapa.gov/regions/RM/ 

environment/Pages/CX2021.aspx. Look 

for the file entitled ‘‘2021–091 LAP 2025 

Resource Pool CX.’’ 

B. Review Under Paperwork Reduction 

Act 

In accordance with the Paperwork 

Reduction Act (44 U.S.C. 3501 et seq.), 

WAPA has received approval from the 

Office of Management and Budget for 

the collection of customer information 

in this rule, under OMB control number 

1910–5136. 

C. Determination Under Executive Order 

12866 

WAPA has an exemption from 

centralized regulatory review under 

Executive Order 12866; accordingly, no 

clearance of this notice by the Office of 

Management and Budget is required. 

Signing Authority 

This document of the Department of 

Energy was signed on September 10, 

2021, by Tracey A. LeBeau, 

Administrator, Western Area Power 

Administration, pursuant to delegated 

authority from the Secretary of Energy. 

That document, with the original 

signature and date, is maintained by 

DOE. For administrative purposes only, 

and in compliance with requirements of 

the Office of the Federal Register, the 

undersigned DOE Federal Register 

Liaison Officer has been authorized to 

sign and submit the document in 

electronic format for publication, as an 

official document of the Department of 

Energy. This administrative process in 

no way alters the legal effect of this 

document upon publication in the 

Federal Register. 

Signed in Washington, DC, on September 

15, 2021. 

Treena V. Garrett, 

Federal Register Liaison Officer, U.S. 

Department of Energy. 

[FR Doc. 2021–20242 Filed 9–17–21; 8:45 am] 

BILLING CODE 6450–01–P 

FEDERAL DEPOSIT INSURANCE 

CORPORATION 

Notice to All Interested Parties of 

Intent To Terminate Receiverships 

Notice is hereby given that the 

Federal Deposit Insurance Corporation 

(FDIC or Receiver), as Receiver for the 

institutions listed below, intends to 

terminate its receivership for said 

institutions. 

NOTICE OF INTENT TO TERMINATE RECEIVERSHIPS

Fund Receivership name City State 

Date of 

appointment of 

receiver 

10061 ......................... BankUnited, FSB ........................................... Coral Gables ................................................. FL 05/21/2009 

10109 ......................... Bradford Bank ............................................... Baltimore ....................................................... MD 08/28/2009 

10110 ......................... Affinity Bank .................................................. Ventura .......................................................... CA 08/28/2009 

10116 ......................... Vantus Bank .................................................. Sioux City ...................................................... IA 09/04/2009 

10126 ......................... San Joaquin Bank ......................................... Bakersfield ..................................................... CA 10/16/2009 

10128 ......................... First Dupage Bank ........................................ Westmont ...................................................... IL 10/23/2009 

10143 ......................... Prosperan Bank ............................................ Oakdale ......................................................... MN 11/06/2009 

10148 ......................... Century Bank, FSB ....................................... Sarasota ........................................................ FL 11/13/2009 

10149 ......................... Orion Bank .................................................... Naples ........................................................... FL 11/13/2009 

10156 ......................... Greater Atlantic Bank .................................... Reston ........................................................... VA 12/04/2009 

10163 ......................... New South Federal Savings Bank ................ Irondale ......................................................... AL 12/18/2009 

10168 ......................... Horizon Bank ................................................. Bellingham ..................................................... WA 01/08/2010 

10423 ......................... Tennessee Commerce Bank ........................ Franklin .......................................................... TN 01/27/2012 

10531 ......................... The Enloe State Bank ................................... Cooper ........................................................... TX 05/31/2019 

The liquidation of the assets for each 

receivership has been completed. To the 

extent permitted by available funds and 

in accordance with law, the Receiver 

will be making a final dividend 

payment to proven creditors. 

52154 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

Based upon the foregoing, the 

Receiver has determined that the 

continued existence of the receiverships 

will serve no useful purpose. 

Consequently, notice is given that the 

receiverships shall be terminated, to be 

effective no sooner than thirty days after 

the date of this notice. If any person 

wishes to comment concerning the 

termination of any of the receiverships, 

such comment must be made in writing, 

identify the receivership to which the 

comment pertains, and be sent within 

thirty days of the date of this notice to: 

Federal Deposit Insurance Corporation, 

Division of Resolutions and 

Receiverships, Attention: Receivership 

Oversight Department 34.6, 1601 Bryan 

Street, Dallas, TX 75201. 

No comments concerning the 

termination of the above-mentioned 

receiverships will be considered which 

are not sent within this time frame. 

(Authority: 12 U.S.C. 1819) 

Federal Deposit Insurance Corporation. 

Dated at Washington, DC, on September 

14, 2021. 

James P. Sheesley, 

Assistant Executive Secretary. 

[FR Doc. 2021–20223 Filed 9–17–21; 8:45 am] 

BILLING CODE 6714–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0611] 

Questions and Answers on Biosimilar 

Development and the Biologics Price 

Competition and Innovation Act of 

2009; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a revised 

final guidance for industry entitled 

‘‘Questions and Answers on Biosimilar 

Development and the BPCI Act.’’ The 

question and answer (Q&A) format is 

intended to inform prospective 

applicants and facilitate the 

development of proposed biosimilars 

and proposed interchangeable 

biosimilars, and also describes FDA’s 

interpretation of certain statutory 

requirements added by the Biologics 

Price Competition and Innovation Act of 

2009 (BPCI Act). This guidance 

document revises the final guidance 

document entitled ‘‘Questions and 

Answers on Biosimilar Development 

and the BPCI Act’’ issued December 12, 

2018. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 20, 2021. 

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– 

2011–D–0611 for ‘‘Questions and 

Answers on Biosimilar Development 

and the BPCI Act.’’ 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, 240–402–7500. 

• 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, 240–402–7500. 

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, or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document.