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. 

Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 52155 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1132, 

Silver Spring, MD 20993, 301–796– 

1042, Sandra.Benton@fda.hhs.gov or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911, Stephen.Ripley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised final guidance for industry 

entitled ‘‘Questions and Answers on 

Biosimilar Development and the BPCI 

Act.’’ The Q&A format is intended to 

inform prospective applicants and 

facilitate the development of proposed 

biosimilars and proposed 

interchangeable biosimilars, and also 

describe FDA’s interpretation of certain 

statutory requirements added by the 

BPCI Act. 

The BPCI Act created an abbreviated 

licensure pathway in section 351(k) of 

the PHS Act (42 U.S.C. 262(k)) for 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 

product (see sections 7001 through 7003 

of the Patient Protection and Affordable 

Care Act (Pub. L. 111–148)). FDA 

believes that guidance for industry that 

provides answers to commonly asked 

questions regarding FDA’s 

interpretation of the BPCI Act will 

enhance transparency and facilitate the 

development and approval of biosimilar 

and interchangeable products. FDA 

intends to update this guidance to 

include additional Q&As as appropriate. 

FDA issues biosimilar Q&A guidances 

that contain Q&As about biosimilar and 

interchangeable products. This final 

guidance document contains all Q&As 

that are in final form. The November 

2020 draft guidance entitled 

‘‘Biosimilarity and Interchangeability: 

Additional Draft Q&As on Biosimilar 

Development and the BPCI Act’’ 

(Additional Draft Q&A Guidance) and 

the draft guidance entitled ‘‘New and 

Revised Draft Q&As on Biosimilar 

Development and the BPCI Act 

(Revision 3)’’ (New and Revised Draft 

Q&A Guidance) contain draft Q&As. 

After FDA has considered any 

comments on the Q&As contained in the 

draft guidances, received during the 

relevant comment period and, as 

appropriate, incorporated suggested 

changes to the Q&A, individual Q&As 

will be moved to the final guidance 

document. This final guidance 

document contains Q&As that have been 

through the public comment process 

and reflects FDA’s current thinking on 

the topics described. 

This guidance document revises the 

final guidance document entitled 

‘‘Questions and Answers on Biosimilar 

Development and the BPCI Act’’ to 

clarify and update certain Q&As and 

add additional Q&As. For certain Q&As, 

FDA updated the Q&A by referring the 

reader to a separate guidance document 

that provides additional information on 

the topic. In addition, a Q&A may be 

withdrawn and removed from the Q&A 

guidance documents if, for instance, the 

issue addressed in the Q&A has been 

addressed in a separate FDA guidance 

document. 

FDA has maintained the original 

numbering of the Q&As used in the 

December 2018 final guidance, 

‘‘Questions and Answers on Biosimilar 

Development and the BPCI Act,’’ the 

December 2018 draft guidance, ‘‘New 

and Revised Draft Q&As on Biosimilar 

Development and the BPCI Act 

(Revision 2),’’ and the Additional Draft 

Q&A Guidance. 

TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS

Q&A category Q&A No. Previous guidance 

location 

Current guidance 

location 

Part I. Biosimilarity or Interchangeability.Q.I.1 .............................................. Final .............................................. Final. 

Q.I.2 .............................................. Final .............................................. Final. 

Q.I.3 .............................................. Final .............................................. Final. 

Q.I.4 .............................................. Final .............................................. Final. 

Q.I.5 .............................................. Final .............................................. Final. 

Q.I.6 .............................................. Final .............................................. Final. 

Q.I.7 .............................................. Final .............................................. Final. 

Q.I.8 .............................................. Final .............................................. Final. 

Q.I.9 .............................................. Final .............................................. Final. 

Q.I.10 ............................................ Final .............................................. Final. 

Q.I.11 ............................................ Withdrawn ..................................... Withdrawn. 

Q.I.12 ............................................ Draft .............................................. Draft.* 

Q.I.13 ............................................ Final .............................................. Final. 

Q.I.14 ............................................ Final .............................................. Final. 

Q.I.15 ............................................ Final .............................................. Final. 

Q.I.16 ............................................ Draft .............................................. Final. 

Q.I.17 ............................................ Final .............................................. Final. 

Q.I.18 ............................................ Final .............................................. Final. 

Q.I.19 ............................................ Final .............................................. Final. 

Q.I.20 ............................................ Draft .............................................. Final. 

Q.I.21 ............................................ Draft .............................................. Final. 

Q.I.22 ............................................ Draft .............................................. Final. 

Q.I.23 ............................................ Draft .............................................. Withdrawn. 

Q.I.24 ............................................ Draft .............................................. Final. 

Q.I.25 ............................................ ....................................................... Draft. 

Q.I.26 ............................................ ....................................................... Draft. 

Q.I.27 ............................................ ....................................................... Draft. 

Q.I.28 ............................................ ....................................................... Draft. 

Part II. Provisions Related to Requirements to Submit a Biologics 

License Application (BLA) for a 

‘‘Biological Product’’.

Q.II.1 ............................................. Draft .............................................. Withdrawn. 

Q.II.2 ............................................. Final .............................................. Final. 

52156 Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices 

TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued 

Q&A category Q&A No. Previous guidance 

location 

Current guidance 

location 

Q.II.3 ............................................. Final .............................................. Final. 

Part III. Exclusivity ......................... Q.III.1 ............................................ Final .............................................. Final. 

Q.III.2 ............................................ Final .............................................. Final. 

* The draft Q&A continues to be available in the New and Revised Draft Q&A Guidance (Revision 3). All other draft Q&As are available in the 

Additional Draft Q&A Guidance. 

This guidance finalizes all but three of 

the Q&As that were included in the 

draft guidance ‘‘New and Revised Draft 

Q&As on Biosimilar Development and 

the BPCI Act (Revision 2)’’ issued on 

December 12, 2018. FDA considered 

comments it received regarding these 

Q&As, and made changes to the Q&As, 

as appropriate; for example, providing 

additional and clearer information in 

Q.I.16 and providing additional 

information about text in the labeling 

for a biosimilar in Q.I.22. FDA also 

made certain clarifying and editorial 

changes to update previously finalized 

Q&As. Editorial changes were made 

primarily for clarification. 

FDA has retained Q.I.12 in draft and 

transferred it to ‘‘New and Revised Draft 

Q&As on Biosimilar Development and 

the BPCI Act (Revision 3).’’ This draft 

Q&A addresses how an applicant can 

demonstrate that its proposed injectable 

biosimilar product or proposed 

injectable interchangeable product has 

the same ‘‘strength’’ as the reference 

product. FDA withdrew Q.I.23, which 

addressed a process for obtaining 

certain letters related to reference 

product access for testing for products 

with risk evaluation and mitigation 

strategy with elements to assure safe 

use. In light of the enactment of the 

Further Consolidated Appropriations 

Act, 2020 (FCA Act) (Pub. L. 116–94), 

which includes provisions related to 

this topic (see Division N, section 610, 

of the FCA Act (21 U.S.C. 355–2)), FDA 

intends to issue guidance describing 

how the existing process for obtaining 

these letters is being aligned with the 

framework set forth in the new law. 

FDA also withdrew Q.II.1, which 

addressed the definition of ‘‘protein.’’ 

For information on the definition of 

‘‘protein’’ in section 351(i)(1) of the PHS 

Act, see the final rule entitled 

‘‘Definition of the Term ‘Biological 

Product’ ’’ (85 FR 10057, February 21, 

2020; 21 CFR 600.3(h)(6)). 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘Questions and 

Answers on Biosimilar Development 

and the BPCI Act.’’ 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 312 for 

submission of an investigational new 

drug application have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR part 314.50 for submission of a new 

drug application have been approved 

under OMB control number 0910–0001. 

The collections of information in 

section 351(a) of the PHS Act and 21 

CFR part 601 for submission of a 

biologics license application (BLA) have 

been approved under OMB control 

number 0910–0338. The collections of 

information in section 351(k) of the PHS 

Act and 21 CFR part 601 for submission 

of a BLA have been approved under 

OMB control number 0910–0719. 

III. Electronic Access 

Persons with access to the internet 

may obtain the final guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.regulations.gov. 

Dated: September 14, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20255 Filed 9–17–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Council on Migrant Health 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

National Advisory Council on Migrant 

Health (NACMH or Council) has 

scheduled a public meeting. Information 

about NACMH and the agenda for this 

meeting can be found on the NACMH 

website at: https://bphc.hrsa.gov/ 

qualityimprovement/strategic

partnerships/nacmh. 

DATES: November 2–5, 2021; 12:30 

p.m.–4:30 p.m. Eastern Time each day. 

ADDRESSES: This meeting will be held 

by webinar. Instructions for joining the 

meeting will be posted on the NACMH 

website 30 business days before the 

meeting date. For meeting information 

updates, go to the NACMH website at: 

https://bphc.hrsa.gov/quality

improvement/strategicpartnerships/ 

nacmh. 

FOR FURTHER INFORMATION CONTACT: 

Esther Paul, NACMH Designated 

Federal Officer, Strategic Initiatives and 

Planning Division, Office of Policy and 

Program Development, Bureau of 

Primary Health Care, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; 301–594–4300; or epaul@

hrsa.gov. 

SUPPLEMENTARY INFORMATION: NACMH 

is a non-discretionary advisory body 

mandated by the Public Health Service 

Act, Title 42 U.S.C. 218, to advise, 

consult with, and make 

recommendations to the Secretary of the 

Department of Health and Human 

Services and the Administrator of HRSA 

regarding the organization, operation, 

selection, and funding of migrant health 

centers and other entities funded under 

section 330(g) of the Public Health