51900 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

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

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: September 13, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20064 Filed 9–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1967] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Biosimilars User 

Fee Program 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with the Agency’s 

Biosimilars User Fee Program. 

DATES: Submit either electronic or 

written comments on the collection of 

information by November 16, 2021. 

ADDRESSES: 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 November 16, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of November 16, 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– 

2018–N–1967 for ‘‘Biosimilars User Fee 

Program.’’ 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: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 51901 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Biosimilars User Fee Program 

OMB Control Number 0910–0718— 

Revision 

This information collection supports 

FDA’s Biosimilars User Fee Program. 

The Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act) 

amended the Public Health Service Act 

(PHS Act) to create an abbreviated 

approval pathway for biological 

products shown to be biosimilar to or 

interchangeable with an FDA-licensed 

reference biological product. Section 

351(k) of the PHS Act (42 U.S.C. 262(k)), 

added by the BPCI Act, allows a 

company to apply for licensure of a 

biosimilar or interchangeable biological 

product (351(k) application). The BPCI 

Act also amended section 735 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 379g) to include 351(k) 

applications as a type of application 

under ‘‘human drug application’’ for the 

purposes of the prescription drug user 

fee provisions. 

The Biosimilar User Fee Act of 2012 

(BsUFA) authorizes FDA to assess and 

collect user fees for certain activities in 

connection with biosimilar biological 

product development (BPD). BsUFA 

was reauthorized for an additional 5 

years in August 2017 (BsUFA II). We 

developed the guidance entitled 

‘‘Assessing User Fees Under the 

Biosimilar User Fee Amendments of 

2017’’ to assist industry in 

understanding when fees are incurred 

and the process by which applicants can 

submit payments. The guidance also 

explains how respondents can request 

discontinuation from the BPD program 

as well as how respondents can request 

to move products to the discontinued 

section of the biosimilar list. Finally, the 

guidance provides information on the 

consequences of failing to pay BsUFA II 

fees as well as processes for submitting 

reconsideration and appeal requests. 

The guidance is available on the FDA 

website at: https://www.fda.gov/media/ 

134567/download. The guidance was 

issued consistent with our Good 

Guidance Practice regulations in 

§ 10.115 (21 CFR 10.115), which provide 

for public comment at any time. 

We also developed Form FDA 3792, 

the Biosimilars User Fee Cover Sheet, 

which is submitted by each new BPD 

entrant (identified via a new meeting 

request or investigational new drug 

(IND) submission) and for new biologics 

license applications (BLAs). Form FDA 

3792 requests the minimum necessary 

information to identify the request, to 

determine the amount of the fee to be 

assessed, and to account for and track 

user fees. The form provides a crossreference of the fees submitted for an 

activity with the actual submission or 

activity by using a unique number 

tracking system. The information 

collected is used by FDA’s Center for 

Drug Evaluation and Research and 

Center for Biologics Evaluation and 

Research to initiate the administrative 

screening of biosimilar biological 

product INDs and BLAs and to account 

for and track user fees associated with 

BPD meetings. 

In addition to Form FDA 3792, the 

information collection includes an 

annual survey of all BsUFA II 

participants designed to provide 

information to FDA of anticipated 

BsUFA II activity in the upcoming fiscal 

year. This information helps FDA set 

appropriate annual BsUFA II fees. 

For efficiency of Agency operations, 

we are consolidating related information 

collection currently approved in OMB 

control number 0910–0719. Specifically 

we are including our current 

commitment goals as set forth in the 

document ‘‘BsUFA Reauthorization 

Performance Goals and Procedures 

Fiscal Years 2018 Through 2022,’’ 

which represents the product of FDA 

discussions with regulated industry and 

public stakeholders, as mandated by 

Congress. The document, referred to as 

the ‘‘BsUFA II letter,’’ is available on 

our website at: https://www.fda.gov/ 

downloads/ForIndustry/UserFees/ 

BiosimilarUserFeeActBsUFA/ 

UCM521121.pdf. The performance and 

procedural goals specified in the BsUFA 

II letter apply to aspects of the 

biosimilar biological product review 

program that are important for 

facilitating timely access to safe and 

effective biosimilar medicines for 

patients. Among those considerations is 

providing feedback to requests from 

regulated industry. Each year, FDA 

review staff participate in many 

meetings with requesters who seek 

advice relating to the development and 

review of a biosimilar or 

interchangeable product. Because these 

meetings often represent critical points 

in the regulatory and development 

process, it is important that there are 

clear procedures for the timely and 

effective conduct of such meeting. 

Accordingly, we issued draft guidance, 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of BsUFA 

Products,’’ available on our website at: 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/formal-meetings-betweenfda-and-sponsors-or-applicants-bsufaproducts-guidance-industry. The 

guidance was issued consistent with 

Section I, Part 6 of the BsUFA II letter 

(see p. 25), and with our Good Guidance 

practice regulations in § 10.115, which 

provide for public comment at any time. 

The guidance provides procedural 

instruction helpful to respondents and 

helps us reach what we believe is a 

more accurate burden estimate for the 

information collection. 

Also available from our website is our 

Biosimilars Action Plan (BAP), which 

discusses key actions the Agency is 

taking to encourage innovation and 

competition among biologics and the 

development of biosimilars. The BAP 

builds on progress in implementing the 

approval pathway for biosimilar and 

interchangeable products, and provides 

interested persons with updates and 

resource material. 

We estimate the burden of this 

collection of information as follows: 

51902 Federal Register / Vol. 86, No. 178 / Friday, September 17, 2021 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

FDA form; survey Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(hours) 

Total hours 

Biosimilar User Fee Cover Sheet (Form FDA 3792) .......... 60 1 60 0.5 (30 minutes).30 

Annual Survey ..................................................................... 60 1 60 1 ..................... 60 

Request for discontinuation from BPD program ................. 10 1 10 1 ..................... 10 

Request to move products to discontinued section of the 

Biosimilar List.

5 1 5 0.5 (30 minutes).2.5 

Biosimilar product applications (351(k)(2)(A)) ..................... 4 2.25 9 860 ................. 7,740 

Interchangeable product applications (351(k)(2)(B) ............ 2 1 2 860 ................. 1,720 

Patent infringement notifications ......................................... 4 2.25 9 2 ..................... 18 

Formal Meetings GFI Recommendations ........................... 69 2.30 159 21.42 .............. 3,405 

Total .............................................................................. ........................ ........................ 314 ........................ 12,985.5 

In anticipation of increased 

participation in the BPD program, we 

have increased our estimate to reflect an 

increase in the number of respondents 

since last OMB review. We have also 

made adjustments to reflect information 

collection consolidated from OMB 

control number 0910–0719. We invite 

comment on our estimates and 

assumptions. 

Dated: September 9, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–20060 Filed 9–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–0990–0313] 

Agency Information Collection 

Request; 30-Day Public Comment 

Request 

AGENCY: Office of the Secretary, Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before October 18, 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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: 

Sherrette Funn, Sherrette.Funn@hhs.gov 

or (202) 795–7714. When submitting 

comments or requesting information, 

please include the document identifier 

0990–0313–30D and project title for 

reference. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

Title of the Collection: 2021 National 

Blood Collection & Utilization Survey. 

Type of Collection: Revision. 

OMB No. 0990–0313: Office of the 

Assistant Secretary for Health. 

Abstract: The 2021 National Blood 

Collection and Utilization Survey is a 

biennial survey of the blood collection 

and utilization community to produce 

reliable and accurate estimates of 

national and regional collections, 

utilization and safety of all blood 

products. The survey includes a core of 

standard questions on blood collection, 

processing, and utilization practices. 

The rapidly changing environment in 

blood supply and demand makes it 

important to have regular, periodic data 

describing the state of U.S. blood 

collections and transfusions for 

understanding the dynamics of blood 

safety and availability. Two sections 

were added to the survey to capture 

information on the impact of the 

COVID–19 pandemic on the blood 

supply during the course of 2020. The 

COVID–19 supplemental sections will 

only be included on the survey once. 

Survey respondents will consist of 

blood collection centers, cord blood 

banks, and hospitals that perform blood 

transfusions, except those reporting 

fewer than 100 inpatient surgeries per 

year. For the purposes of this ICR, 

federal burden is only being placed on 

facilities located within the fifty states 

and the District of Columbia. 

OMB approval is requested for three 

years. The total estimated annual 

burden is 4,532 hours. 

ESTIMATED ANNUALIZED BURDEN TABLE

Type of respondent Number of 

respondents 

Number 

responses 

per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

Transfusing Hospitals ...................................................................................... 2,140 1 2 4,280 

Hospital Blood Banks ...................................................................................... 76 1 2 152 

Community-based blood center ....................................................................... 50 1 2 100