Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 52685 

4027, Attn: August 30, 2021 ACIP 

Meeting. 

Instructions: All submissions received 

must include the Agency name and 

Docket Number. All relevant comments 

received in conformance with the 

https://www.regulations.gov suitability 

policy will be posted without change to 

https://www.regulations.gov, including 

any personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. 

In accordance with 41 CFR 102– 

3.150(b), less than 15 calendar days’ 

notice is being given for this meeting 

due to the exceptional circumstances of 

the COVID–19 pandemic and rapidly 

evolving COVID–19 vaccine 

development and regulatory processes. 

The Secretary of Health and Human 

Services has determined that COVID–19 

is a Public Health Emergency. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Thomas, ACIP Committee 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road 

NE, MS–H24–8, Atlanta, GA 30329– 

4027; Telephone: 404–639–8367; Email: 

ACIP@cdc.gov. 

Public Participation 

Written Public Comment: The docket 

will close on August 30, 2021. Written 

comments must be received on or before 

August 30, 2021. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2021–20478 Filed 9–21–21; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0921] 

B. Braun Medical, Inc.; Withdrawal of 

Approval of Abbreviated New Drug 

Application of Hydroxyethyl Starch 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of abbreviated 

new drug application (ANDA) 

BA110013/0032 for 6 Percent 

Hydroxyethyl Starch 130/0.4 in 0.9 

Percent Sodium Chloride Injection in 

EXCEL® Plastic Container, held by B. 

Braun Medical, Inc. B. Braun Medical, 

Inc., requested in writing that the 

Agency’s approval of the application be 

withdrawn because the drug is no 

longer being marketed and has waived 

its opportunity for a hearing. 

DATES: Approval is withdrawn as of 

October 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, 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. 

SUPPLEMENTARY INFORMATION: B. Braun 

Medical Inc., 901 Marcon Blvd., 

Allentown, PA 18109, has requested 

that FDA withdraw approval of ANDA 

BA110013/0032, pursuant to 

§ 314.150(c) (21 CFR 314.150(c)), 

because the drug is no longer being 

marketed. By its request, B. Braun 

Medical Inc. has also waived its 

opportunity for a hearing. Withdrawal 

of approval of an application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Proprietary name 

ANDA BA 110013/0032 ..... 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection in EXCEL® Plastic Container. 

Therefore, approval of the application 

listed in the table, and all amendments 

and supplements thereto, is hereby 

withdrawn as of October 22, 2021. 

Introduction or delivery for introduction 

into interstate commerce for products 

without an approved new drug 

application or ANDA violates section 

301(a) and (d) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 331(a) and 

(d)). The drug product that is listed in 

the table above that is in inventory on 

October 22, 2021 may continue to be 

dispensed until the inventory has been 

depleted or the drug product has 

reached its expiration date or otherwise 

becomes violative, whichever occurs 

first. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20511 Filed 9–21–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3326] 

Reauthorization of the Biosimilar User 

Fee Act; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

hosting a virtual public meeting to 

discuss proposed recommendations for 

the reauthorization of the Biosimilar 

User Fee Act (BsUFA) for fiscal years 

(FYs) 2023 through 2027. The BsUFA 

authorizes FDA to collect user fees to 

support the process for the review of 

biosimilar biological product 

applications. The current legislative 

authority for BsUFA expires in 

September 2022. At that time, new 

legislation will be required for FDA to 

continue collecting user fees in future 

fiscal years. Following discussions with 

the regulated industry and consultations 

with public stakeholders, the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) directs FDA to publish the 

recommendations for the reauthorized 

program in the Federal Register, hold a 

meeting at which the public may 

present its views on such 

recommendations, and provide for a 

period of 30 days for the public to 

provide written comments on such 

recommendations. FDA will then 

consider such public views and 

comments and revise such 

recommendations, as necessary. 

DATES: The public meeting will be held 

on November 2, 2021, from 9 a.m. to 12 

p.m. Eastern Time, and will be held by 

webcast only. Submit either electronic 

or written comments on this public 

52686 Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 

meeting by December 2, 2021. See 

SUPPLEMENTARY INFORMATION for 

registration date and information. 

ADDRESSES: Registration to attend the 

meeting and other information can be 

found at https://bsufaiiifinalpublicmeeting.eventbrite.com. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before December 2, 2021. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until 11:59 p.m. Eastern Time at the end 

of December 2, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked, and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–3326 for ‘‘Reauthorization of 

the Biosimilar User Fee Act; Public 

Meeting; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 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. 

FOR FURTHER INFORMATION CONTACT: 

Emily Ewing, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 240–402–0196, 

Emily.Ewing@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

FDA is announcing a virtual public 

meeting to discuss proposed 

recommendations for the 

reauthorization of BsUFA, the 

legislation that authorizes FDA to 

collect user fees to support the process 

for the review of biosimilar biological 

product applications. The current 

authorization of the program (BsUFA II) 

expires in September 2022. Without 

new legislation, FDA will no longer be 

able to collect user fees for future FYs 

to fund the process for the review of 

biosimilar biological product 

applications. Section 744I(f)(2) of the 

FD&C Act (21 U.S.C. 379j–53(f)(2)) 

requires the Agency perform the 

following actions after holding 

negotiations with regulated industry 

members: (1) Present recommendations 

to the relevant Congressional 

committees; (2) publish 

recommendations in the Federal 

Register, (3) provide a period of 30 days 

for the public to provide written 

comments on the recommendations; (4) 

hold a meeting at which the public may 

present its views; and (5) after 

consideration of public views and 

comments, revise the recommendations 

as necessary. 

This notice, the 30-day comment 

period, and the public meeting will 

satisfy some of these requirements. After 

the public meeting, we will revise the 

recommendations as necessary and 

present our proposed recommendations 

to the Congressional committees. 

The purpose of the meeting is to hear 

the public’s views on the proposed 

recommendations for the reauthorized 

program (BsUFA III). The following 

information is provided to help 

potential meeting participants better 

understand the history and evolution of 

the BsUFA program and the status of the 

proposed BsUFA III recommendations. 

II. What is BsUFA and what does it do? 

BsUFA is a law that authorizes FDA 

to assess and collect fees from drug 

companies that submit marketing 

applications for certain biosimilar 

biological products. BsUFA was 

originally enacted in 2012 as the 

Biosimilar User Fee Act under the Food 

and Drug Administration Safety and 

Innovation Act (FDASIA, Pub. L. 112– 

144) for a period of 5 years. In 2017, 

BsUFA was renewed for 5 more years 

under the FDA Reauthorization Act of 

2017 (FDARA, Pub. L. 115–52). 

BsUFA is intended to provide 

additional revenues so that FDA can 

hire staff, improve systems, and 

continue a well-managed biosimilar 

Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 52687 

biological product review process to 

make biosimilar biological product 

therapies available to patients sooner 

without compromising review quality or 

FDA’s high standards for safety, 

efficacy, and quality. As part of FDA’s 

agreements with industry during prior 

BsUFA authorizations, the Agency 

agreed to certain performance and 

procedural goals and other 

commitments. These goals apply to the 

process for the review of biosimilar 

biological product applications, 

including biosimilar biological product 

development meetings, review of 

applications and supplements, and 

other review activities. FDA’s web page 

‘‘Biosimilar User Fee Amendments’’ 

provides more information about 

BsUFA, including the statutory text of 

FDARA, the BsUFA commitment letter, 

‘‘Biosimilar Authorization Performance 

Goals and Procedures Fiscal Years 2013 

through 2017’’ (BsUFA Commitment 

Letter), key Federal Register documents, 

BsUFA-related guidances, BsUFA user 

fee rates, performance reports, and 

financial reports. The Agency’s 

‘‘Biosimilar User Fee Amendments’’ 

web page is available at https://

www.fda.gov/industry/fda-user-feeprograms/biosimilar-user-feeamendments. 

With the current authorization of 

BsUFA II under FDARA, FDA 

implemented a review program (‘‘the 

Program’’) to promote the efficiency and 

effectiveness of the first cycle review 

process. The Program allows for 

additional communication between the 

FDA review team and applicants of 

biosimilar biological products, 

including mid-cycle communications 

and late-cycle meetings, while adding 

60 days to the review clock to provide 

for this increased interaction and to 

address review issues. BsUFA II also 

includes commitments to advance 

development of biosimilar biological 

products through further clarification of 

the regulatory pathway that permits a 

biosimilar biological product to be 

licensed under section 351(k) of the 

Public Health Service Act, and to 

enhance capacity for biosimilar 

guidance development, reviewer 

training, and timely communication. 

More information on these 

commitments can be found in the 

BsUFA II Commitment Letter at https:// 

www.fda.gov/media/100573/download. 

As part of the current authorization, 

FDA established an independent fee 

structure and fee amounts to improve 

program funding predictability, 

stability, and administrative efficiency. 

The new structure established a BsUFA 

target revenue based on BsUFA program 

costs and updated the overall fee 

structure and related financial 

mechanisms. The agreement also 

included commitments to enhance 

management of user fee resources 

through the development of a resource 

capacity planning capability and thirdparty evaluation of program resource 

management, management of the 

carryover balance, along with the 

publication and annual update of a 5- 

year financial plan. 

The current authorization also 

includes several commitments to 

improve the hiring and retention of 

critical review staff through 

modernization of FDA’s hiring system, 

augmentation of hiring staff capacity 

and capabilities, creation of a dedicated 

function focused on staffing the 

program, reporting on hiring metrics, 

and a comprehensive and continuous 

assessment of hiring and retention. A 

list of the deliverables developed to 

meet BsUFA II commitments is 

available on the FDA web page https:// 

www.fda.gov/industry/biosimilar-userfee-amendments/completed-bsufa-iideliverables. 

III. Proposed BsUFA III 

Recommendations 

In preparing the proposed 

recommendations to Congress for 

BsUFA reauthorization, FDA conducted 

discussions with regulated industry 

members, as required by the law. We 

began the BsUFA reauthorization 

process by publishing a notice in the 

Federal Register requesting public input 

on the reauthorization and announcing 

a public meeting that was held on 

November 19, 2020. The meeting 

included presentations by FDA and a 

series of panels with representatives of 

different stakeholder groups, including 

patient advocates, consumer groups, 

regulated industry members, health 

professionals, and academic researchers. 

The materials from the meeting, 

including a transcript and webcast 

recording, can be found at https://

www.fda.gov/industry/biosimilar-userfee-amendments/public-meetingreauthorization-biosimilar-user-fee-actbsufa-11192020-11192020. 

Following the November 2020 public 

meeting, FDA conducted negotiations 

with regulated industry from March 

2021 through June 2021. As directed by 

Congress, FDA posted minutes of these 

meetings on its web page at https://

www.fda.gov/industry/biosimilar-userfee-amendments/bsufa-iii-fiscal-years2023-2027. 

The proposed enhancements for 

BsUFA III address many of the top 

priorities identified by public 

stakeholders, regulated industry, and 

FDA. While some of the proposed 

enhancements are new, many either 

build on successful enhancements or 

refine elements from the existing 

program. The enhancements are 

proposed in the following areas: 

Supplemental applications, meeting 

management, best practices in 

communication between FDA and 

sponsors, inspections and alternative 

tools, interchangeable biosimilar 

biological product development, 

regulatory science, finance, hiring and 

retention, and information technology. 

The full text of the proposed BsUFA III 

Commitment Letter can be found on the 

Agency’s web page ‘‘BsUFA III: Fiscal 

Years 2023—2027,’’ available at https:// 

www.fda.gov/industry/biosimilar-userfee-amendments/bsufa-iii-fiscal-years2023-2027. Each significant new or 

modified enhancement is described 

briefly below: 

A. Original and Resubmitted 

Supplemental Biosimilar Biological 

Product Applications 

To expedite the review of 

supplemental biosimilar biological 

product applications, FDA proposes to 

establish new supplement categories, 

timelines, and performance goals. New 

review timelines range from 3 to 10 

months, depending on the content and 

category of the supplement submission. 

Certain supplements for safety labeling 

updates and labeling updates to add or 

remove an indication that do not 

contain efficacy data sets would have 

shorter review timelines than 

supplements in other categories. These 

enhancements are described in section 

I.A.2 of the proposed BsUFA III 

Commitment Letter. 

B. Meeting Management Goals 

To improve overall meeting 

management, FDA proposes to modify 

the Biosimilar Initial Advisory (BIA) 

meeting, create a new Type 2a meeting, 

and modify the timing of Type 4 

meeting background packages. FDA 

would not require the submission of 

preliminary comparative analytical data 

for a BIA meeting. The new Type 2a 

meeting would allow for quicker 

discussion on a narrow set of issues 

(e.g., often one but no more than two 

issues) involving no more than three 

review disciplines or divisions. 

Traditional Type 2 meetings under 

BsUFA II would be renamed to Type 2b 

meetings in BsUFA III. Under this 

proposal, the Type 4 meeting 

background package may be submitted 

up to 14 calendar days after FDA 

receives the meeting request. There 

would also be a new followup 

opportunity to pose clarifying questions 

after meetings or a written-responseVerDate Sep<11>2014 16:44 Sep 21, 2021 Jkt 253001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\22SEN1.SGM 22SEN1
52688 Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 

only communication. These 

enhancements are described in section 

I.H of the proposed BsUFA III 

Commitment Letter. 

C. Promoting Best Practices in 

Communication Between FDA and 

Sponsors During Application Review 

To enhance communication with 

sponsors during biosimilar biologic 

product application review, FDA 

proposes to update relevant guidances, 

our Manual of Policies and Procedures, 

and our Standard Operating Procedures 

and Policies regarding best practices in 

communication. FDA would utilize 

lessons learned from BsUFA II to update 

the relevant documents, as appropriate. 

The details of this enhancement are 

found in section II.A of the proposed 

BsUFA III Commitment Letter. 

D. Enhancing Inspection 

Communication and Alternative Tools 

To facilitate the timely development 

of biosimilar biological products and 

their availability to patients, FDA 

proposes to notify sponsors of certain 

pre-license inspections and to issue 

guidance on FDA’s thinking on the use 

of alternative tools to assess 

manufacturing facilities beyond the 

COVID–19 pandemic. These 

enhancements are described in section 

II.B of the proposed BsUFA III 

Commitment Letter. 

E. Advancing Development of Biosimilar 

Biological-Device Combination Products 

Regulated by CDER and CBER 

Sponsors employ Use-Related Risk 

Analyses (URRA) studies to identify the 

need for risk mitigation strategies and to 

design a human factors (HF) validation 

study. Based on a URRA, a sponsor may 

propose that a HF validation study is 

not needed to support the safe and 

effective use of a biosimilar biologicdevice combination product. FDA 

proposes establishing new procedures 

for the review of URRAs along with 

performance goals. Human factors 

studies are conducted to evaluate the 

user interface of a biosimilar biologicdevice combination product to 

eliminate or mitigate use-related 

hazards that may affect the safe and 

effective use of the combination 

product. Over the past decade, more 

combination products have been 

developed to deliver therapeutics via 

different routes of administration (e.g., 

parenteral, inhalation) with complex 

engineering designs. HF validation 

protocols are reviewed during the 

investigational new drug application 

stage with the goal towards developing 

a final finished combination product 

that supports the marketing application. 

To achieve this objective, FDA proposes 

updating the procedures for HF 

validation study protocols, along with a 

new performance goal. These 

enhancements are described in section 

II.C of the proposed BsUFA III 

Commitment Letter. 

F. Advancing Development of 

Interchangeable Biosimilar Biological 

Products 

FDA proposes a focused effort in 

BsUFA III to further advance the 

development of safe and effective 

interchangeable biosimilar biological 

products. This effort would address 

current needs, prospectively identify 

future needs, and incorporate the 

following components: (1) Research 

leveraging the BsUFA III Regulatory 

Science Pilot Program; (2) foundational 

guidance development; and (3) 

stakeholder engagement involving a 

scientific workshop on the development 

of interchangeable biosimilar biological 

products to help identify future needs. 

Associated with this workshop, FDA 

would issue draft and final strategy 

documents outlining FDA’s actions to 

facilitate the development of 

interchangeable biosimilar biological 

products. The details of this 

enhancement are described in section 

II.D of the proposed BsUFA III 

Commitment Letter. 

G. Regulatory Science 

To enhance regulatory decisionmaking and facilitate science-based 

recommendations in areas foundational 

to biosimilar biological product 

development, FDA proposes to pilot a 

regulatory science program broadly 

applicable to biosimilar and 

interchangeable biological product 

development, with project goals not 

specific to a product or product class. 

The pilot program would focus on two 

demonstration projects: (1) Advancing 

the development of interchangeable 

biosimilar biological products and (2) 

improving the efficiency of biosimilar 

biological product development. As part 

of these demonstration projects, FDA 

proposes to engage stakeholders in a 

public meeting to review the progress of 

the demonstration projects and to solicit 

input of future priorities. An interim 

report would be issued prior to the 

public meeting, and a final summary 

report of outcomes from the pilot 

program would be posted on FDA’s 

website. Within 12 months of 

completing the demonstration projects, 

FDA would publish a comprehensive 

strategy document outlining actions 

FDA will take to facilitate the 

development of biosimilar and 

interchangeable biological products. 

These enhancements are described in 

section II.E of the proposed BsUFA III 

Commitment Letter. 

H. Continued Enhancement of User Fee 

Resource Management 

FDA is committed to ensuring the 

sustainability of BsUFA program 

resources and to enhancing the 

operational agility of the BsUFA 

program. FDA proposes to build on the 

financial enhancements included in 

BsUFA II and continue activities in 

BsUFA III to ensure optimal use of user 

fee resources and the alignment of staff 

to workload through the continued 

maturation and assessment of the 

Agency’s resource capacity planning 

capability. This proposal would also 

include an independent assessment of 

the resource capacity planning 

capability. FDA proposes to continue 

activities to promote transparency of the 

use of financial resources in support of 

the BsUFA program through annual 

public meetings, publishing a 5-year 

financial plan along with annual 

updates, and additional reporting in the 

annual BsUFA Financial Report. These 

enhancements are described in section 

III of the proposed BsUFA III 

Commitment Letter. 

I. Information Technology 

FDA proposes to establish and 

progress a data and technology 

modernization strategy that provides 

FDA’s strategic direction for current and 

future state data-driven regulatory 

initiatives. Additionally, FDA would 

advance the use of cloud-based 

technology to modernize the Electronic 

Submission Gateway to support greater 

data submission bandwidth and storage 

in the BsUFA program. These 

enhancements are described in section 

V of the proposed BsUFA III 

Commitment Letter. 

J. Enhancements to Fee Mechanisms for 

Increased Predictability, Stability, and 

Efficiency 

The proposed BsUFA III agreement 

continues to build on the resource 

capacity planning capability established 

in BsUFA II and continues financial 

transparency initiatives. In addition, to 

manage financial risks in the program, 

BsUFA III proposes to enhance the 

operating reserve adjustment 

mechanism to provide for a defined 

minimum and maximum required 

amount of operating reserves. The 

proposed minimum amount is 

equivalent to 10 weeks of operating 

reserves and the maximum amount is 

equivalent to 21 weeks of available 

operating reserves to be maintained 

each year. The annual maximum 

Federal Register / Vol. 86, No. 181 / Wednesday, September 22, 2021 / Notices 52689 

amount of available operating reserves 

would be phased in over the first 3 years 

of BsUFA III (33 weeks in fiscal year 

2023, 27 weeks in fiscal year 2024, and 

21 weeks in fiscal year 2025). BsUFA III 

also proposes to add a strategic hiring 

and retention adjustment to ensure FDA 

has the funding necessary to provide for 

the costs of retaining and hiring highly 

qualified scientific and technical staff 

for the process for the review of 

biosimilar biological product 

applications under BsUFA. This 

strategic hiring and retention 

adjustment would add $150,000 to the 

base revenue amount each fiscal year 

during BsUFA III. 

K. Impact of BsUFA III Enhancements 

on User Fee Revenue 

To implement the proposed 

enhancements for BsUFA III, funding 

for a cumulative total of 15 FTE staff is 

proposed to be phased in over the 

course of BsUFA III. The new funding 

would be phased in as follows: 

• $4,428,886 for fiscal year 2023 

• $320,569 for fiscal year 2024 

IV. Public Meeting Information 

A. Purpose and Scope of the Meeting 

The virtual public meeting will 

include a presentation by FDA and an 

industry panel. For members of the 

public who would like to make verbal 

comments on the proposed 

enhancements, there will be a public 

comment period at the end of the 

meeting (see instructions below). We 

will also provide an opportunity for 

individuals to submit written comments 

to the docket before and after the 

meeting. 

B. Participating in the Public Meeting 

Registration: Registration is optional 

and not required to attend this virtual 

public meeting. However, registering 

will allow FDA to provide you with 

email updates if any meeting details 

change. If you wish to register, you can 

do so at https://bsufaiii-finalpublic

meeting.eventbrite.com. 

Opportunity for Verbal Public 

Comment: Those who register online 

will receive a confirmation email that 

includes a link to a request form to 

make a verbal public comment at the 

meeting. If you wish to speak during the 

public comment session, follow the 

instructions in the notification and 

identify which topic(s) you wish to 

address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

comments and request time jointly. All 

requests to make a public comment 

during the meeting must be received by 

October 19, 2021, 11:59 p.m. Eastern 

Time. Depending on the number of 

requests, we will determine the amount 

of time allotted to each commenter, the 

approximate time each comment is to 

begin, and will select and notify 

participants by October 26, 2021. No 

commercial or promotional material 

will be permitted to be presented at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: The Zoom Webinar ID for this 

public meeting is 161 047 8285. The 

webcast link for this public meeting can 

be found here: https://fda.zoomgov.

com/j/1610478285?pwd=MG1lN2hr

YzBVTGhsd1F2eVhwZG1DQT09. The 

link above should allow you to enter the 

webinar directly. If Zoom asks for a 

passcode, please use the case-sensitive 

passcode below. 

Case-Sensitive Passcode for Zoom 

Webinar: S9d&fx 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). Transcripts of the 

meeting will be available on the FDA 

web page https://www.fda.gov/industry/ 

biosimilar-user-fee-amendments/bsufaiii-fiscal-years-2023-2027 approximately 

30 days after the meeting. 

Dated: September 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20432 Filed 9–21–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission to OMB for 

Review and Approval; Public Comment 

Request; Information Collection 

Request Title: Bureau of Primary 

Health Care—Program Management 

Resource Compendium, 0906–XXXX, 

New 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA has submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than October 22, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Samantha Miller, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

9094. 

SUPPLEMENTARY INFORMATION:

Information Collection Request Title: 

Bureau of Primary Health Care— 

Program Management Resource 

Compendium, OMB No. 0906–XXXX, 

New. 

Abstract: The Program Management 

Resource Compendium project will 

encompass an historical analysis of 

HRSA’s Bureau of Primary Health Care 

(BPHC), as well as a historical analysis 

of the Health Center Program, performed 

by federal contractors. Dating from the 

founding of the initial community 

health centers in the mid-1960s up to 

the present time, the analysis will 

consider the evolution and critical 

milestones of BPHC and the Health 

Center Program based on documentary 

research and interviews with 

individuals with historical knowledge 

of the Health Center Program and the 

health center movement. 

A 60-day notice published in the 

Federal Register (86 FR 30962 (June 10, 

2021). There were no public comments. 

Need and Proposed Use of the 

Information: The information gathered 

through interviews will be combined 

with information drawn from 

documentary research to inform the 

historical analysis. The results of the 

analysis will be presented in 

communication products for an internal 

audience, as well as products for an 

external audience. The goals of the 

project are to increase awareness of the 

Health Center Program management