0746 Program Evaluation SSA 2019 Ext

UNITED STATES FOOD & DRUG ADMINISTRATION
Review Transparency and Communication in Reviews
of 351(k) Biologics License Applications in Biosimilars User Fee Act
OMB Control No. 0910-0746
SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, the agency, we or us)
programs, specifically, evaluation of those performance goals and procedures set forth in what is
known as FDA’s “goals letter” or “commitment letter” under the Prescription Drug User Fee Act
(PDUFA) and, more recently, the Biosimilar User Fee Act (BsUFA). The goals letter is the
result of agency, industry, and public input, as Congressionally mandated under the applicable
statutes. Recently PDUFA was reauthorized, together with the Biosimilar User Fee Act of 2012.
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 the renewed 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.p
df; and
https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM5211
21.pdf.
To implement these performance goals, we established a review program (hereafter referred to as
“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.
The BsUFA II Commitment Letter specifies that an independent contractor can conduct the
assessments and specifies that they include interviews of sponsors who submit 351(k) BLAs to
the Program in BsUFA II. Currently, Eastern Research Group, Inc. (ERG) is the contractor for
the assessments of the Program. In accordance with the PDUFA and BsUFA Commitment
Letters, FDA contracted with ERG to conduct independent interviews of applicants after FDA
issues a first-cycle action for applications reviewed under the Program. The purpose of these
interviews is to collect feedback from applicants on the success of the Program in increasing
transparency and communication of reviews during the review process. ERG will anonymize
and aggregate sponsor responses before inclusion in the assessments and presentation materials
at public meetings, and we will publish the findings in the Federal Register.

Accordingly, we are requesting extension of OMB approval for the information collection
provisions associated with the Program and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The ERG has prepared a protocol and script for scheduling and conducting interviews with
applicants after their 351(k) BLA receives a first review cycle action from FDA. The protocol
ensures that ERG is aware of all applicants who are candidates for interviews and schedules and
conducts post-action interviews in a timely, consistent manner using good interview practices.
The script includes open-ended questions aimed at obtaining a thorough understanding of
applicants’ experiences and insights about the review process for their application under the
Program.
To design and prepare for this information collection, FDA consulted with the contractor, ERG,
which has program evaluation and interview experts on staff. Similarly, ERG consulted
corporate experts outside its independent assessment project team to obtain input and feedback
on this information collection.
The ERG will analyze open-ended responses to identify practices that applicants perceive as
enhancing review process transparency, practices that applicants perceive as increasing the
efficiency of the review process, and aspects of Program implementation that might benefit from
improvement. In addition, ERG will consider how interview responses might explain or provide
context for results from other parts of the independent assessment, such as metrics pertaining to
presubmission meetings, mid-cycle communications, late-cycle meetings, and other Program
elements. In this way, ERG will use interview responses to complement and supplement data on
Program parameters obtained through other means. ERG will synthesize and interpret the results
to develop a set of findings and recommendations for the Program to be included in interim and
final assessment reports and presentations.
In turn, FDA will use the independent assessment results, findings, and recommendations
to:
 determine the success of the Program in achieving established goals;
 determine whether and how to refine implementation of the Program during the
remainder of BsUFA II;
 demonstrate compliance with the commitment to conduct the independent assessments
 and publish them for public comment; and
 share information about the Program with the regulated community, the public health
community, Congress, and the general public.
3. Use of Improved Information Technology and Burden Reduction
ERG will not employ any web-based resources in soliciting sponsor and FDA feedback. While
online surveys can be distributed quickly and easily to a large volume of respondents, they are
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not the best vehicle for discussing the nuances of respondent’s individual experiences, insights,
and reasoning. Even surveys with open-ended questions do not permit immediate follow-up
exchanges to clarify or elucidate responses; any follow-up requires additional contact with
respondents. Interviews provide the more detailed and nuanced feedback needed for this
independent assessment in a way that minimizes burden.
ERG will also minimize the burden by offering to conduct interviews by telephone or
videoconference if meeting in person is burdensome. Finally, the interview instrument has been
designed to elicit the desired feedback in as short an interview time as possible.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. Although there are many regulations
applicable to drug and biologic applications submitted to the agency, this information collection
provides for assessments of our Program independent of those activities and is consistent with
goals articulated in the Commitment Letter.
5. Impact on Small Businesses or Other Small Entities
The information collection poses no undue burden on small entities. Respondents will not be
asked to travel, or incur telephone charges or other unusual expenses.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with agency, industry, and Congressional
timeframes, in accordance with the Program goals and Commitment Letter.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60-day notice inviting public comment in
the Federal Register of March 12, 2019 (84 FR 8877); no comments were received.
9. Explanation of Any Payment or Gift to Respondents
Respondents will not receive any payments or gifts for participating in this information
collection.

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10. Assurance of Confidentiality Provided to Respondents
Although there is no express assurance of confidentiality that cannot be supported by law, the
design of the data collection will allow responses to be anonymous. Interviewees will be assured
of the privacy, to the extent available under law, of their responses through language placed
prominently on all interview materials as well as introductory comments made by the
interviewer. Interviewers will be trained on the privacy of responses and will be prepared to
describe the policy in detail, provide examples, and respond to any related questions from
participants. For example, the interviewer will explain that each individual’s answers will be
combined with those of others and presented in summary form only, and that FDA will not have
access to the names of participants.
All responses that could identify specific sponsors (no responses will identify any individuals)
will be kept only by the contractor, ERG, for use in analysis. Any data received by FDA will not
contain personal identifiers, thus precluding individual identification. Public use data files
produced at the end of the study will follow the current OMB checklist on confidentiality to
ensure that they can be distributed to the general public for analysis without restrictions and
without identification of interviewees.
After evaluation with our Privacy office, we have determined that the subject information
collection does not involve solicitation or collection of personally identifiable information (PII)
by or on behalf of FDA/CDER. Specifically, FDA/CDER does not intend to collect PII and will
not maintain records subject to the Privacy Act or otherwise operate a Privacy Act System of
Records in relation to this proposed collection.
11. Justification for Sensitive Questions
There are no questions of a sensitive nature associated with the information collection.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden for the information collection as follows:
Table 1.--Estimated Annual Reporting Burden
Information Collection
Activity

Pre-test
Interviews
Total

No. of
Respondents

No. of
Responses per
Respondent

5
135

1
1

Total
Annual
Responses

Average Burden
per Response

5
135

1.5
1.5

Total
Hours

7.5
202.5
210

We typically review 40 to 45 NME NDAs and original BLAs annually, and potentially twenty-

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five (25) 351(k) BLAs per year. ERG interviews 1 to 3 sponsor representatives at a time for
each application that receives a first-cycle action from FDA, up to 135 sponsor representatives
per year. ERG conducts a pretest of the interview protocol with five respondents. We estimate it
takes 1.0 to 1.5 hours to complete the pretest, for a total of a maximum of 7.5 hours. We
estimate that up to 135 respondents will take part in the post-action interviews each year, with
each interview lasting 1.0 to 1.5 hours, for a total of a maximum of 202.5 hours. Thus, the total
estimated annual burden is 210 hours. Our estimate is based on our prior experience with the
Program and communications with the regulated community.
12b. Annualized Cost Burden Estimate
To estimate the annualized cost to respondents, we multiplied the total number of burden
hours by an hourly wage estimate of $90.00 (Source: Occupational Employment Statistics,
Bureau of Labor Statistics). Using Standard Occupational Code (SOC) 29-1069, we used
calculated a median figure representing a range of wages for NDA/BLA managers in the
pharmaceutical industry. We also multiplied this median wage by 1.4 to capture benefits,
resulting in a loaded hourly median wage rate of $126.00.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, or operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
The annualized cost to the Federal government is estimated to be $50,000, which represents the
total contractor cost of conducting the interview portion of the independent assessment project.
Out of a total allotment of $265,000 for a five year period, $15,000 was budgeted for interview
development costs (e.g., instrument development, implementation design, etc.) and $250,000
was budgeted for interview implementation and analysis. There are no other costs to the Federal
government.
15. Explanation for Program Changes or Adjustments
Based on a review of the information collection since our last request for OMB approval, we
have made no adjustments to our burden estimate.
16. Plans for Tabulation and Publication and Project Time Schedule
The ERG will present results, including interview results, in two reports:


Assessment of the Program for Enhanced Review Transparency and Communication for
351(k) BLAs in BsUFA II: Interim Report; and

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

Assessment of the Program for Enhanced Review Transparency and Communication for
351(k) BLAs in BsUFA II: Final Report.

FDA will publish these reports, or links to the reports, in the Federal Register.
Tasks

Table 3. Schedule for Project Tasks
Schedule

Draft post-action interview protocol and script
Finalize post-action interview protocol and script
Conduct post-action interviews

October 2, 2017
October 23, 2017
Approximately 2 weeks after applications
receive a
first review cycle action from FDA (through)
Quarterly throughout BsUFA II
November 30, 2020

Analyze interview information
Prepare interim assessment report February 15,
2015
Prepare final assessment report

February 15, 2022

17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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