Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40567 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

EFUDEX (fluorouracil) topical 

solution, 5 percent, is the subject of 

NDA 016831, held by Bausch Health 

Americas, Inc., and initially approved 

on July 29, 1970. EFUDEX is indicated 

for the topical treatment of multiple 

actinic or solar keratoses, and treatment 

of superficial basal cell carcinomas 

when conventional methods are 

impractical, such as with multiple 

lesions or difficult treatment sites. 

EFUDEX (fluorouracil) topical solution, 

5 percent, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Encube Ethicals Private Ltd. 

submitted a citizen petition dated 

March 16, 2021 (Docket No. FDA–2021– 

P–0299), under 21 CFR 10.30, 

requesting that the Agency determine 

whether EFUDEX (fluorouracil) topical 

solution, 5 percent, was withdrawn 

from sale for reasons of safety or 

effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that EFUDEX (fluorouracil) 

topical solution, 5 percent, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that EFUDEX (fluorouracil) 

topical solution, 5 percent, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of EFUDEX 

(fluorouracil) topical solution, 5 

percent, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list EFUDEX (fluorouracil) 

topical solution, 5 percent, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. FDA will not 

begin procedures to withdraw approval 

of the approved ANDA that refers to this 

drug product. Additional ANDAs that 

refer to EFUDEX (fluorouracil) topical 

solution, 5 percent, may also be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16037 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0708] 

Biosimilar User Fee Rates for Fiscal 

Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the rates for biosimilar user 

fees for fiscal year (FY) 2022. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the 

Biosimilar User Fee Amendments of 

2017 (BsUFA II), authorizes FDA to 

assess and collect user fees for certain 

activities in connection with biosimilar 

biological product development; review 

of certain applications for approval of 

biosimilar biological products; and each 

biosimilar biological product approved 

in a biosimilar biological product 

application. BsUFA II directs FDA to 

establish, before the beginning of each 

fiscal year, the amount of initial and 

annual biosimilar biological product 

development (BPD) fees, the 

reactivation fee, and the biosimilar 

biological product application and 

program fees for such year. These fees 

apply to the period from October 1, 

2021, through September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 744G, 744H, and 744I of the 

FD&C Act (21 U.S.C. 379j-51, 379j-52, 

and 379j-53), as amended by BsUFA II 

(title IV of the FDA Reauthorization Act 

of 2017, Pub. L. 115–52), authorize the 

collection of fees for biosimilar 

biological products. Under section 

744H(a)(1)(A) of the FD&C Act, the 

initial BPD fee for a product is due 

when the sponsor submits an 

investigational new drug (IND) 

application that FDA determines is 

intended to support a biosimilar 

biological product application or within 

5 calendar days after FDA grants the 

first BPD meeting, whichever occurs 

first. A sponsor who has paid the initial 

BPD fee is considered to be participating 

in FDA’s BPD program for that product. 

Under section 744H(a)(1)(B) of the 

FD&C Act, once a sponsor has paid the 

initial BPD fee for a product, the annual 

BPD fee is assessed beginning with the 

next fiscal year. The annual BPD fee is 

assessed for the product each fiscal year 

until the sponsor submits a marketing 

application for the product that is 

accepted for filing or the sponsor 

discontinues participation in FDA’s 

BPD program for the product. 

Under section 744H(a)(1)(D) of the 

FD&C Act, if a sponsor has discontinued 

participation in FDA’s BPD program and 

wants to reengage with FDA on 

development of the product, the sponsor 

must pay a reactivation fee to resume 

participation in the program. The 

sponsor must pay the reactivation fee by 

the earlier of the following dates: No 

later than 5 calendar days after FDA 

grants the sponsor’s request for a BPD 

meeting for that product or upon the 

date of submission by the sponsor of an 

IND describing an investigation that 

FDA determines is intended to support 

a biosimilar biological product 

application for that product. The 

sponsor will be assessed an annual BPD 

fee beginning with the first fiscal year 

after payment of the reactivation fee. 

BsUFA II also authorizes fees for 

certain biosimilar biological product 


khammond on DSKJM1Z7X2PROD with NOTICES
40568 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

1The Bureau of Labor Statistics’ announcement of 

the geographical revision can be viewed at https:// 

www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm. 

applications and for each biosimilar 

biological product identified in an 

approved biosimilar biological product 

application (section 744H(a)(2) and (3) 

of the FD&C Act). Under certain 

conditions, FDA will grant a small 

business a waiver from its first 

biosimilar biological product 

application fee (section 744H(d)(1) of 

the FD&C Act). 

For FY 2018 through FY 2022, the 

base revenue amounts for the total 

revenues from all BsUFA fees are 

established by BsUFA II. For FY 2022, 

the base revenue amount is the FY 2021 

inflation-adjusted fee revenue amount of 

$42,493,066. The FY 2022 base revenue 

amount is to be adjusted for inflation 

and to reflect changes in the resource 

capacity needs for the process for the 

review of biosimilar biological product 

applications. Additionally, it may be 

reduced, as appropriate, for long-term 

financial planning purposes. 

This document provides fee rates for 

FY 2022 for the initial and annual BPD 

fee ($57,184), for the reactivation fee 

($114,368), for an application requiring 

clinical data ($1,746,745), for an 

application not requiring clinical data 

($873,373), and for the program fee 

($304,162). These fees are effective on 

October 1, 2021, and will remain in 

effect through September 30, 2022. For 

applications that are submitted on or 

after October 1, 2021, the new fee 

schedule must be used. 

II. Fee Revenue Amount for FY 2022 

The base revenue amount for FY 2022 

is $42,493,066 prior to adjustments for 

inflation, resource capacity, and 

operating reserves (see section 

744H(c)(1) through (3) of the FD&C Act). 

A. FY 2022 Statutory Fee Revenue 

Adjustments for Inflation 

BsUFA II specifies that the 

$42,493,066 is to be adjusted for 

inflation increases for FY 2022 using 

two separate adjustments—one for 

personnel compensation and benefits 

(PC&B) and one for non-PC&B costs (see 

section 744H(c)(1) of the FD&C Act). 

The component of the inflation 

adjustment for payroll costs shall be one 

plus the average annual percent change 

in the cost of all PC&B paid per full-time 

equivalent (FTE) positions at FDA for 

the first 3 of the preceding 4 fiscal years, 

multiplied by the proportion of PC&B 

costs to total FDA costs of the process 

for the review of biosimilar biological 

product applications for the first 3 of the 

preceding 4 fiscal years (see section 

744H(c)(1)(B) of the FD&C Act). 

Table 1 summarizes the actual cost 

and FTE data for the specified fiscal 

years and provides the percent changes 

from the previous fiscal years and the 

average percent changes over the first 3 

of the 4 fiscal years preceding FY 2022. 

The 3-year average is 2.7383 percent. 

TABLE 1—FDA PC&B EACH YEAR AND PERCENT CHANGES

Fiscal year 2018 2019 2020 3-Year average 

Total PC&B ...................................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ............................

Total FTE ......................................................................................... 17,023 17,144 17,535 ............................

PC&B per FTE ................................................................................. $158,061 $152,826 $163,992 ............................

Percent Change From Previous Year ............................................. 4.2206% -3.3120% 7.3063% 2.7383% 

The statute specifies that this 2.7383 

percent be multiplied by the proportion 

of PC&B costs to the total FDA costs of 

the process for the review of biosimilar 

biological product applications. Table 2 

shows the PC&B and the total 

obligations for the process for the 

review of biosimilar biological product 

applications for the first 3 of the 

preceding 4 fiscal years. 

TABLE 2—PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF BIOSIMILAR BIOLOGICAL

PRODUCT APPLICATIONS

Fiscal year 2018 2019 2020 3-Year average 

Total PC&B ...................................................................................... $35,477,032 $32,946,252 $25,445,175 ............................

Total Costs ....................................................................................... $62,604,122 $65,210,467 $56,798,694 ............................

PC&B Percent .................................................................................. 56.6688% 50.5230% 44.7989% 50.6636% 

The payroll adjustment is 2.7383 

percent from table 1 multiplied by 

50.6636 percent (or 1.3873 percent). 

The statute specifies that the portion 

of the inflation adjustment for 

nonpayroll costs is the average annual 

percent change that occurred in the 

Consumer Price Index (CPI) for urban 

consumers (Washington-Baltimore, DC– 

MD–VA–WV; not seasonally adjusted; 

all items; annual index) for the first 3 

years of the preceding 4 years of 

available data multiplied by the 

proportion of all costs other than PC&B 

costs to total costs of the process for the 

review of biosimilar biological product 

applications for the first 3 years of the 

preceding 4 fiscal years (see section 

744H(c)(1)(B) of the FD&C Act). As a 

result of a geographical revision made 

by the Bureau of Labor and Statistics in 

January 2018,1 the WashingtonBaltimore, DC–MD–VA–WV index was 

discontinued and replaced with two 

separate indices (i.e., WashingtonArlington-Alexandria, DC–VA–MD–WV 

and Baltimore-Columbia-Towson, MD). 

In order to continue applying a CPI 

which best reflects the geographic 

region in which FDA is headquartered 

and which provides the most current 

data available, the WashingtonArlington-Alexandria index will be used 

in calculating the relevant adjustment 

factors for FY 2020 and subsequent 

years. Table 3 provides the summary 

data for the percent changes in the 

specified CPI for the WashingtonArlington-Alexandria area. The data are 

published by the Bureau of Labor 

Statistics and can be found on its 

website at: https://data.bls.gov/pdq/ 

SurveyOutputServlet?data_

tool=dropmap&series_

id=CUURS35ASA0,CUUSS35ASA0. 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40569 

2Full-time equivalents refers to a paid staff year, 

rather than a count of individual employees. 

TABLE 3—ANNUAL AND THREE-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA

AREA

Year 2018 2019 2020 3-Year 

average 

Annual CPI ....................................................................................................... 261.445 264.777 267.157 ........................

Annual Percent Change .................................................................................. 2.0389% 1.2745% 0.8989% 1.4041% 

The statute specifies that this 1.4041 

percent be multiplied by the proportion 

of all costs other than PC&B to total 

costs of the process for the review of 

biosimilar biological product 

applications obligated. Since 50.6636 

percent was obligated for PC&B (as 

shown in table 2), 49.3364 percent is the 

portion of costs other than PC&B (100 

percent minus 50.6636 percent equals 

49.3364 percent). The nonpayroll 

adjustment is 1.4041 percent times 

49.3364 percent, 0.6927 percent. 

Next, we add the payroll adjustment 

(1.3873 percent) to the nonpayroll 

adjustment (0.6927 percent), for a total 

inflation adjustment of 2.0800 percent 

(rounded) for FY 2022. 

We then multiply the base revenue 

amount for FY 2022 ($42,493,066) by 

one plus the inflation adjustment 

(1.0208), yielding an inflation-adjusted 

amount of $43,376,922. 

B. FY 2022 Statutory Fee Revenue 

Adjustments for Capacity Planning 

The statute specifies a process to 

establish and implement a capacity 

planning adjustment (CPA) to adjust the 

total revenue amount to reflect changes 

in the resource capacity needs for the 

process for the review of biosimilar 

biological product applications (see 

section 744H(c)(2) of the FD&C Act). 

Following a process required in statute, 

FDA established the capacity planning 

adjustment methodology and first 

applied it in the setting of FY 2021 fees. 

The establishment of this new 

methodology is described in the Federal 

Register at 85 FR 47220. 

The CPA methodology consists of four 

steps: 

1. Forecast workload volumes: 

predictive models estimate the volume 

of workload for the upcoming fiscal 

year. 

2. Forecast the resource needs: 

Forecast algorithms are generated 

utilizing time reporting data. These 

algorithms estimate the required 

demand in FTEs 2 for direct reviewrelated effort. This is then compared to 

current available resources for the direct 

review-related workload. 

3. Assess the resource forecast in the 

context of additional internal factors: 

Program leadership examines 

operational, financial, and resourcing 

data to assess whether the FDA will be 

able to utilize additional funds during 

the fiscal year and the funds are 

required to support additional review 

capacity. FTE amounts are adjusted, if 

needed. 

4. Convert the FTE need to dollars: 

utilizing the FDA’s fully loaded FTE 

cost model, the final feasible FTEs are 

converted to an equivalent dollar 

amount. 

The following section outlines the 

major components of the FY 2022 

BsUFA CPA. Table 4 summarizes the 

forecasted workload volumes for BsUFA 

in FY 2022 based on predictive models, 

as well as historical actuals from FY 

2020 for comparison. 

TABLE 4—BSUFA ACTUAL FY 2020 WORKLOAD VOLUMES & PREDICTED FY 2022 WORKLOAD VOLUMES

Workload category FY 2020 

actuals 

FY 2022 

predictions 

Supplements with Clinical Data ............................................................................................................................... 2 4 

Labeling Supplements ............................................................................................................................................. 4 8 

Manufacturing Supplements .................................................................................................................................... 79 111 

Biosimilar Biological Product Applications ............................................................................................................... 7 7 

BsUFA Industry Meetings (BIA, BPD Type 1–4) .................................................................................................... 95 120 

Participating BPD Programs .................................................................................................................................... 104 131 

Utilizing the resource forecast 

algorithms, the forecasted workload 

volumes for FY 2022 were then 

converted into estimated FTE needs for 

FDA’s BsUFA direct review-related 

work. The resulting expected FY 2022 

FTE need for BsUFA was compared to 

current onboard capacity for BsUFA 

direct review-related work to determine 

the FY 2022 resource delta, as 

summarized in table 5. 

TABLE 5—FY 2022 BSUFA 

RESOURCE DELTA

Current 

resource 

capacity 

FY 2022 

resource 

forecast 

Predicted 

FY 2022 

FTE delta 

54 71 17 

The projected 17 FTE delta was then 

assessed by FDA in the context of 

additional operational and internal 

factors to ensure that a fee adjustment 

is only made for resources which can be 

utilized in the fiscal year and for which 

funds are required to support additional 

review capacity. FDA determined that 

the expected net FTE gains could be 

funded through the expected FY 2022 

collections amount without a further 

adjustment from the CPA. In summary, 

after accounting for these internal 

factors, FDA determined that in FY 2022 

the BsUFA fee amounts did not need 

adjustment from the CPA to provide 

funds for the realistic estimated net FTE 

gains. 


khammond on DSKJM1Z7X2PROD with NOTICES
40570 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

3See: https://www.fda.gov/media/100573/ 

download. 

TABLE 6—FY 2022 BSUFA CPA 

Additional 

FTEs for 

FY 2022 

Cost for 

each 

additional 

FTE 

FY 2022 

BsUFA CPA 

0 $312,185 $0 

Although an adjustment to the fee 

amounts for resource needs by the CPA 

will not be made in FY 2022, FDA will 

evaluate the need for a fee adjustment 

from the CPA in future fiscal years and 

will make adjustments as warranted. 

C. FY 2022 Statutory Fee Revenue 

Adjustments for Operating Reserve 

BsUFA II provides for an operating 

reserve adjustment to allow FDA to 

adjust the fee revenue and fees for any 

given fiscal year during BsUFA II, after 

FY 2018, to maintain an appropriate 

operating reserve of carryover user fees. 

Beginning in FY 2019, FDA may reduce 

the fee revenue and fees for long-term 

financial planning purposes. Once the 

capacity planning adjustment is 

effective, FDA also may, if necessary, 

increase the fee revenue and fees to 

maintain not more than 21 weeks of 

operating reserve of carryover user fees. 

As described in the BsUFA II 

commitment letter, Biosimilar Biological 

Product Reauthorization Goals and 

Procedures Fiscal Years 2018 Through 

2022,3 FDA is committed to reducing 

the BsUFA carryover reserve to an 

amount no greater than 21 weeks of 

operating reserve of carryover user fees 

by the end of FY 2022. Based on 

estimates published in the FY 2021 

update to the BsUFA II Five-Year 

Financial Plan, FDA currently shows an 

operating reserve amount that currently 

exceeds the committed amount. As 

such, FDA is applying a downward 

operating reserve adjustment of 

$3,336,686 (rounded to the nearest 

dollar), an amount equivalent to 4 

weeks of operations. With this operating 

reserve adjustment, the inflationadjusted amount, $43,376,922, will be 

lowered by $3,336,686, yielding the FY 

2022 target revenue amount of 

$40,040,000 (rounded to the nearest 

thousand). 

III. Fee Amounts for FY 2022 

Under section 744H(b)(3)(A) of the 

FD&C Act, FDA must determine the 

percentage of the total revenue amount 

for a fiscal year to be derived from: (1) 

Initial and annual BPD fees and 

reactivation fees; (2) biosimilar 

biological product application fees; and 

(3) biosimilar biological product 

program fees. In establishing the fee 

amounts for the final year of BsUFA II, 

FDA considered how best to balance the 

fee allocation to provide stable funding 

and reasonable fee amounts. 

A. Application Fees 

In establishing the biosimilar 

biological product application fee 

amount for FY 2022, FDA utilized an 

average of the 3 most recently 

completed fiscal years (i.e., FY 2018– 

2020) of biosimilar biological product 

application submissions. Based on the 

available information, FDA estimates it 

will receive 7 biosimilar biological 

product applications requiring clinical 

data for approval in FY 2022. 

FDA will maintain the biosimilar 

biological product application fee for FY 

2022 at the same level as FY 2021, 

which is $1,746,745. This is estimated 

to provide a total of $12,227,215 

representing 31 percent (rounded to the 

nearest whole number) of the FY 2022 

target revenue amount. 

B. Biosimilar Biological Product 

Program Fee 

Under BsUFA II, FDA assesses 

biosimilar biological product program 

fees (‘‘program fees’’). An applicant in a 

biosimilar biological product 

application shall not be assessed more 

than five program fees for a fiscal year 

for biosimilar biological products 

identified in a single biosimilar 

biological product application (see 

section 744H(a)(3)(D) of the FD&C Act). 

Applicants are assessed a program fee 

for a fiscal year only for biosimilar 

biological products identified in a 

biosimilar biological product 

application approved as of October 1 of 

such fiscal year. 

Based on available information, FDA 

estimates that 67 program fees will be 

invoiced for FY 2022, including 

currently approved products and 

products with the potential to be 

approved in pending applications with 

goal dates in FY 2021. For products 

invoiced in the FY 2022 regular billing 

cycle, FDA anticipates that zero 

program fees will be refunded. 

FDA will maintain the biosimilar 

biological product program fee for FY 

2022 at the same level as FY 2021, 

which is $304,162. This is estimated to 

provide a total of $20,378,854, 

representing 51 percent (rounded to the 

nearest whole number) of the FY 2022 

target revenue amount. 

C. Initial and Annual BPD Fees, 

Reactivation Fees 

To estimate the number of BPD fees 

to be paid in FY 2022, FDA must 

consider the number of new BPD 

programs, the number of current BPD 

programs, and the number of BPD 

programs that will be reactivated. These 

estimates provide information that, 

when aggregated, allows FDA to set BPD 

fees (initial BPD fees, annual BPD fees, 

reactivation fees). 

FDA analyzes available data to 

estimate the total number of BPD 

programs for FY 2022. In FY 2022, FDA 

estimates 39 new BPD programs, no 

reactivations (a single reactivation is 

weighted as two BPD fees), and 91 BPD 

programs (out of 92 invoiced) to pay the 

annual BPD fee, yielding a total 

estimated equivalent of 130 BPD fees to 

be collected in FY 2022. 

The remainder of the target revenue of 

$7,433,931, or 19 percent (rounded to 

the nearest whole number), is to be 

collected from the BPD fees. Dividing 

this amount by the estimated 130 BPD 

fees to be paid equals an initial BPD and 

annual BPD fee amount of $57,184. The 

reactivation fee is set at twice the 

initial/annual BPD amount at $114,368 

(rounded to the nearest dollar). This 

represents a reduction of the BPD fees 

from the FY 2021 levels. 

IV. Fee Schedule for FY 2022 

The fee rates for FY 2022 are 

displayed in table 7. 

TABLE 7—FEE SCHEDULE FOR FY 

2022 

Fee category Fee rates for 

FY 2022 

Initial BPD ............................. $57,184 

Annual BPD .......................... 57,184 

Reactivation .......................... 114,368 

Applications: 

Requiring clinical data ....... 1,746,745 

Not requiring clinical data 873,373 

Program ................................ 304,162 

V. Fee Payment Options and 

Procedures 

A. Initial BPD, Reactivation, and 

Application Fees 

The fees established in the new fee 

schedule apply to FY 2022, i.e., the 

period from October 1, 2021, through 

September 30, 2022. The initial BPD fee 

for a product is due when the sponsor 

submits an IND that FDA determines is 

intended to support a biosimilar 

biological product application for the 

product or within 5 calendar days after 

FDA grants the first BPD meeting for the 

product, whichever occurs first. 

Sponsors who have discontinued 

participation in the BPD program for a 

product and seek to resume 

participation in such program must pay 

the reactivation fee by the earlier of the 

following dates: No later than 5 calendar 


khammond on DSKJM1Z7X2PROD with NOTICES

I I 
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40571 

1The term ‘‘food’’ for purposes of this document 

has the same meaning as such term in section 201(f) 

of the FD&C Act (21 U.S.C. 321(f)). 

days after FDA grants the sponsor’s 

request for a BPD meeting for that 

product or upon the date of submission 

by the sponsor of an IND describing an 

investigation that FDA determines is 

intended to support a biosimilar 

biological product application for that 

product. 

The application fee for a biosimilar 

biological product is due upon 

submission of the application (see 

section 744H(a)(2)(C) of the FD&C Act). 

To make a payment of the initial BPD, 

reactivation, or application fee, 

complete the Biosimilar User Fee Cover 

Sheet, available on FDA’s website 

(https://www.fda.gov/bsufa) and 

generate a user fee identification (ID) 

number. Payment must be made in U.S. 

currency by electronic check, check, 

bank draft, U.S. postal money order, or 

wire transfer. The preferred payment 

method is online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). FDA has partnered with the 

U.S. Department of the Treasury to use 

Pay.gov, a web-based payment 

application, for online electronic 

payment. The Pay.gov feature is 

available on the FDA website after the 

user fee ID number is generated. Secure 

electronic payments can be submitted 

using the User Fees Payment Portal at 

https://userfees.fda.gov/pay (Note: Only 

full payments are accepted. No partial 

payments can be made online). Once 

you search for your invoice, click ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances that are less 

than $25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

If a check, bank draft, or postal money 

order is submitted, make it payable to 

the order of the Food and Drug 

Administration and include the user fee 

ID number to ensure that the payment 

is applied to the correct fee(s). Payments 

can be mailed to: Food and Drug 

Administration, P.O. Box 979108, St. 

Louis, MO 63197–9000. If a check, bank 

draft, or money order is to be sent by a 

courier that requests a street address, 

the courier should deliver your payment 

to: U.S. Bank, Attention: Government 

Lockbox 979108, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery, contact 

U.S. Bank at 314–418–4013. This 

telephone number is only for questions 

about courier delivery.) Please make 

sure that the FDA post office box 

number (P.O. Box 979108) and ID 

number is written on the check, bank 

draft, or postal money order. 

For payments made by wire transfer, 

include the unique user fee ID number 

to ensure that the payment is applied to 

the correct fee(s). Without the unique 

user fee ID number, the payment may 

not be applied. The originating financial 

institution may charge a wire transfer 

fee. Include applicable wire transfer fees 

with payment to ensure fees are fully 

paid. Questions about wire transfer fees 

should be addressed to the financial 

institution. The following account 

information should be used to send 

payments by wire transfer: U.S. 

Department of the Treasury, TREAS 

NYC, 33 Liberty St., New York, NY 

10045, Acct. No.: 75060099, Routing 

No.: 021030004, SWIFT: FRNYUS33. 

FDA’s tax identification number is 53– 

0196965. 

B. Annual BPD and Program Fees 

FDA will issue invoices with payment 

instructions for FY 2022 annual BPD 

and program fees under the new fee 

schedule in August 2021. Payment will 

be due on October 1, 2021. If sponsors 

join the BPD program after the annual 

BPD invoices have been issued in 

August 2021, FDA will issue invoices in 

December 2021 to firms subject to fees 

for FY 2022 that qualify for the annual 

BPD fee after the August 2021 billing. 

FDA will issue invoices in December 

2021 for any annual program fees for FY 

2022 that qualify for fee assessments 

and were not issued in August 2021. 

Dated: July 23, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16084 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0701] 

Food Safety Modernization Act 

Domestic and Foreign Facility 

Reinspection, Recall, and Importer 

Reinspection Fee Rates for Fiscal Year 

2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the fiscal year (FY) 2022 fee 

rates for certain domestic and foreign 

facility reinspections, failures to comply 

with a recall order, and importer 

reinspections that are authorized by the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act), as amended by the FDA 

Food Safety Modernization Act (FSMA). 

These fees are effective on October 1, 

2021, and will remain in effect through 

September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Jimmy Carlton, Office of Management, 

Office of Regulatory Affairs, Food and 

Drug Administration, 12420 Parklawn 

Dr., Rockville, MD 20857,240–888– 

1556,jimmy.carlton@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 107 of FSMA (Pub. L. 111– 

353) added section 743 to the FD&C Act 

(21 U.S.C. 379j–31) to provide FDA with 

the authority to assess and collect fees 

from, in part: (1) The responsible party 

for each domestic facility and the U.S. 

agent for each foreign facility subject to 

a reinspection, to cover reinspectionrelated costs; (2) the responsible party 

for a domestic facility and an importer 

who does not comply with a recall 

order, to cover food 1 recall activities 

associated with such order; and (3) each 

importer subject to a reinspection to 

cover reinspection-related costs 

(sections 743(a)(1)(A), (B), and (D) of the 

FD&C Act). Section 743 of the FD&C Act 

directs FDA to establish fees for each of 

these activities based on an estimate of 

100 percent of the costs of each activity 

for each year (sections 743(b)(2)(A)(i), 

(ii), and (iv)), and these fees must be 

made available solely to pay for the 

costs of each activity for which the fee 

was incurred (section 743(b)(3)). These 

fees are effective on October 1, 2021, 

and will remain in effect through 

September 30, 2022. Section 

743(b)(2)(B)(iii) of the FD&C Act directs 

FDA to develop a proposed set of 

guidelines in consideration of the 

burden of fee amounts on small 

businesses. As a first step in developing 

these guidelines, FDA invited public 

comment on the potential impact of the 

fees authorized by section 743 of the 

FD&C Act on small businesses (76 FR 

45818, August 1, 2011). The comment 

period for this request ended November 

30, 2011. As stated in FDA’s September 

2011 ‘‘Guidance for Industry: 

Implementation of the Fee Provisions of 

Section 107 of the FDA Food Safety 

Modernization Act,’’ (https://

www.fda.gov/regulatory-information/ 

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