16008 Federal Register / Vol. 87, No. 54 / Monday, March 21, 2022 / Notices 

second authorization of the Biosimilar 

User Fee Act (BsUFA II). The goals 

letters are the result of Agency, 

industry, and public input, as 

Congressionally mandated under the 

applicable statutes. The documents 

entitled ‘‘PDUFA Reauthorization 

Performance Goals and Procedures 

Fiscal Years 2018 Through 2022,’’ and 

‘‘Biosimilar Biological Product 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 Through 

2022’’ represent current performance 

goals agreed to by FDA in support of 

these respective programs. These 

documents are available at: https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf; and https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/BiosimilarUserFeeActBsUFA/ 

UCM521121.pdf. Work to reauthorize 

these authorities from Fiscal Years 2023 

to 2027 is ongoing. 

To implement certain performance 

goals, we established the Program to 

promote greater transparency and 

increased communication between the 

FDA review team and the applicant on 

the most innovative products that we 

review. The Program goals are intended 

to increase the efficiency and 

effectiveness of the first review cycle 

and decrease the number of review 

cycles necessary for approval so that 

patients have timely access to safe, 

effective, and high-quality new drugs 

and biologics. A key aspect of the 

extension of the Program to BsUFA II is 

to conduct an interim and final 

assessment that will evaluate how well 

the parameters of the Program have 

achieved the intended goals. Based on 

sponsors’ responses and other data, on 

December 2, 2020, we published an 

interim report that is available on FDA’s 

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

144130/download. We learned that 

under BsUFA II review, teams have 

been effective in enhancing review 

transparency and communication, with 

milestone meetings also enhancing the 

predictability of the review process. We 

have also adapted certain good practices 

identified through the Program, 

including providing pre-submission 

advice and templates; allocating time for 

applicant-identified discussion topics in 

late-cycle meetings where feasible; and 

recommending request response times 

of greater than 2 days for applicants 

with a global presence. We expect to 

continue these assessments. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Pretest .................................................................................. 5 1 5 1.5 7.5 

Interviews ............................................................................. 75 1 75 1.5 112.5 

Total .............................................................................. ........................ ........................ 80 ........................ 120 

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

We plan interviews with up to three 

applicant representatives per each 

351(k) BLA first-cycle action issued for 

applications reviewed under the 

Program. In addition, a pretest of the 

interview protocol with five 

respondents will also be conducted. 

Based on our prior experience with the 

Program and communications with the 

regulated industry, we assume that five 

applicant representatives will expend 

approximately 1.5 hours to complete the 

pretest, for a total of 7.5 burden hours. 

We further assume that up to 75 

applicant representatives (up to 3 

representatives for each of up to 25 

applications) will participate in the 

post-action interviews each year and 

that each interview will last 

approximately 1.5 hours, for a total of 

120 burden hours. Cumulatively, we 

estimate an overall decrease to the 

information collection, which 

corresponds to a decrease in 

submissions received by the Agency 

over the last 3 years. 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05814 Filed 3–18–22; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, Topics 

in Alzheimer’s Disease, Mild Cognitive 

Impairment and Cognitive Aging, March 

25, 2022, 10:00 a.m. to March 25, 2022, 

8:00 p.m., National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 which was 

published in the Federal Register on 

March 03, 2022, FR Doc. 2022–04426, 

87 FR 12182. 

This meeting is being amended to 

change the Contact Person from 

Maribeth Champoux to Heidi Friedman, 

Ph.D., Center for Scientific Review, 

National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD, 301– 

379–5623. The meeting is closed to the 

public. 

March 15, 2022. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05835 Filed 3–18–22; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, March 

29, 2022, 1:00 p.m. to 6:00 p.m., 

National Institutes of Health, Rockledge 

II, 6701 Rockledge Drive, Bethesda, MD 

20892, which was published in the 

Federal Register on March 04, 2022, V 

87 #43 Page 12467, FR Doc No. 2022– 

04619. 

Meeting is being amended to change 

the Contact Person from Ai-Ping Zou to 

David Jollie, Ph.D., Scientific Review 

Officer, Center for Scientific Review, 

National Institutes of Health. The 

meeting is closed to the public. 

Dated: March 16, 2022. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–05896 Filed 3–18–22; 8:45 am] 

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