Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10371 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

1.914; Waiver petitions ........................................................ 2 1 2 24 48 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We estimate one waiver petition from 

each of two firms will be submitted and 

respondents will spend 24 hours to 

prepare and submit the petition to FDA. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

21 CFR section; activity Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average burden per 

disclosure Total hours 

1.908; Disclosure of sanitary specifications; 

operating temperature conditions.

226 1 226 0.5833 (∼35 minutes) ........... 132 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Finally, we estimate an annual thirdparty disclosure burden of 132 hours, 

assuming each of 226 firms will spend 

an average of 35 minutes, annually, 

disclosing written records as required 

under 21 CFR 1.908. 

Based on an evaluation of the 

information collection, we have made 

no adjustments to our burden estimate. 

Dated: February 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03916 Filed 2–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2252] 

Final Assessment of the Program for 

Enhanced Review Transparency and 

Communication in 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, the Agency, or 

we) is announcing the following virtual 

public meeting entitled ‘‘Final 

Assessment of the Program for 

Enhanced Review Transparency and 

Communication in the Biosimilar User 

Fee Act (BsUFA)’’ (the Program) and an 

opportunity for public comment. The 

topics to be discussed are the final 

assessment and public stakeholder 

views of the Program. 

DATES: The public meeting will be held 

on March 22, 2022, from 9:30 a.m. to 

12:30 p.m. Eastern Time and will be 

held by webcast only. Submit either 

electronic or written comments on this 

public meeting by May 23, 2022. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: Registration to attend the 

meeting and other information can be 

found at https://www.eventbrite.com/e/ 

public-meeting-on-the-final-assessmentof-the-bsufa-ii-program-tickets229459628927. 

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 May 23, 2022. The https:// 

www.regulations.gov electronic filing 

system will accept comments until 

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

May 23, 2022. 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– 

2020–N–2252 for ‘‘Final Assessment of 

the Program for Enhanced Review 

Transparency and Communication in 

the Biosimilar User Fee Act (BsUFA); 

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 


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10372 Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 

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: 

Kimberly Taylor, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 1152, 

Silver Spring, MD 20993, 240–402– 

5193, Kimberly.taylor@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

BsUFA was originally enacted in 2012 

as the Biosimilar User Fee Act under the 

Food and Drug Administration Safety 

and Innovation Act (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) (BsUFA II) (Pub. L. 115–52, 

Title IV)). BsUFA was intended to 

provide additional revenues so that FDA 

can hire staff, improve systems, and 

continue a well-managed biosimilar 

biological product review process to 

make biosimilar biological product 

therapies available to patients sooner. 

BsUFA II was authorized to continue 

the collection of user fees by FDA to 

facilitate and expedite the process for 

the review of biosimilar biological 

products in the United States. 

Under BsUFA II, FDA committed to 

apply a new review model to original 

biosimilar biologics license application 

(BLA) reviews. That review model is 

identified in section II.B. of the BsUFA 

II Commitment Letter as the Program for 

Enhanced Review Transparency and 

Communication for Original 351(k) 

BLAs. The Program provides 

opportunities for increased 

communication between FDA and 

applicants, including mid-cycle and 

late-cycle meetings. To accommodate 

the increased interaction during 

regulatory review, FDA’s review clock 

begins after the 60-day administrative 

filing review period for applications 

reviewed under the Program. The goal 

of the Program is to promote the 

efficiency and effectiveness of the firstcycle review process and minimize the 

number of review cycles necessary for 

approval, ensuring that patients have 

timely access to safe, effective, and 

high-quality biosimilar and 

interchangeable biological products. 

An independent evaluator is assessing 

the Program to understand its effect on 

the review of original 351(k) BLAs. An 

interim assessment was published 

December 3, 2020, and can be accessed 

at https://www.fda.gov/media/144130/ 

download. The BsUFA II performance 

commitments also call for a final 

assessment of the Program to be 

published by June 30, 2022, for public 

comment. The final assessment can be 

accessed at https://www.fda.gov/ 

industry/biosimilar-user-feeamendments/bsufa-ii-assessmentprogram-enhanced-reviewtransparency-and-communicationbiosimilar-user-fee-act. A public 

meeting will be held on March 22, 2022, 

where the final assessment will be 

discussed, and public stakeholders may 

present their views on the Program. 

Additional information concerning 

BsUFA—including the text of the law, 

the ‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 through 

2022’’ (the BsUFA II Commitment 

Letter), ‘‘Biosimilar Authorization 

Performance Goals and Procedures 

Fiscal Years 2013 through 2017’’ (the 

BsUFA Commitment Letter), key 

Federal Register documents, BsUFArelated guidances, BsUFA user fee rates, 

performance reports, and financial 

reports—may be found at https://

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

II. Topics for Discussion at the Public 

Meeting 

FDA and an independent contractor 

will discuss the findings of the final 

assessment, including anonymized and 

aggregated feedback from biosimilar 

BLA applicants and FDA review teams 

resulting from independent contractor 

interviews. FDA will discuss any issues 

identified, including any proposed 

plans to improve the likelihood of the 

Program’s success. A panel of external 

stakeholders will also provide their 

perspectives. 

III. 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://www.eventbrite.com/e/ 

public-meeting-on-the-final-assessmentof-the-bsufa-ii-program-tickets229459628927. 

Opportunity for Verbal Public 

Comment: Those who register online 

will receive a confirmation email that 

includes a link to a request form to 

make 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 

March 10, 2022, 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 March 18, 2022. 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 161 769 1719. The 

webcast link for this public meeting can 

be found here: https://

fda.zoomgov.com/j/ 

1617691719?pwd=dy9yRTVqdEw1d

VEzTUNqelFEa3Vpdz09. This link 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 37 / Thursday, February 24, 2022 / Notices 10373 

should allow you to enter the webinar 

directly. If Zoom asks for a passcode, 

please use the passcode f7DLM=, which 

is case-sensitive. 

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). A link to the 

meeting recording will also be available 

on the internet at https://www.fda.gov/ 

drugs/news-events-human-drugs/publicmeeting-final-assessment-programenhanced-review-transparency-andcommunication-biosimilar. 

Dated: February 18, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03926 Filed 2–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–1311] 

Nonclinical Considerations for 

Mitigating Nonhuman Primate Supply 

Constraints Arising From the COVID– 

19 Pandemic; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Nonclinical Considerations for 

Mitigating Nonhuman Primate Supply 

Constraints Arising from the COVID–19 

Pandemic.’’ The COVID–19 pandemic 

has resulted in a significant reduction in 

the supply of nonhuman primates 

(NHPs) available for conducting 

toxicology studies for new 

pharmaceuticals. This has the potential 

to significantly delay the development 

of new medications for the treatment of 

diseases currently without effective 

treatment options. This guidance 

provides FDA’s recommendations to 

industry to help mitigate the NHP 

supply issue by reducing the demand 

for NHPs during the COVID–19 

pandemic. Given the public health 

emergency presented by COVID–19, this 

guidance document is being 

implemented without prior public 

comment because FDA has determined 

that prior public participation is not 

feasible or appropriate, but it remains 

subject to comment in accordance with 

the Agency’s good guidance practices. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on February 24, 2022. 

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– 

2021–D–1311 for ‘‘Nonclinical 

Considerations for Mitigating 

Nonhuman Primate Supply Constraints 

Arising from the COVID–19 Pandemic.’’ 

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 the 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. 


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