0746 Program Evaluation SSA 2022 Rev

0746 Program Evaluation SSA 2022 Rev.docx

Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs

OMB: 0910-0746

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Review Transparency and Communication in Reviews

of 351(k) Biologics License Applications in Biosimilars User Fee Act

OMB Control No. 0910-0746 - Revision

SUPPORTING STATEMENT – Part A: Justification

1. Circumstances Making the Collection of Information Necessary

This information collection supports the evaluation of certain performance goals and procedures set forth in what is known as FDA’s “goals letter” or “commitment letter” under the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The goals letter is the result of agency, industry, and public input, as Congressionally mandated under the applicable statutes. The document entitled “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027” (PDUFA VII Commitment Letter) represents current performance goals agreed to by FDA in support of these respective programs. The document is available at: https://www.fda.gov/media/151712/download. To implement certain performance goals, we established a review program (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 process 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 is to conduct an interim and final assessment that will evaluate how well the parameters of the Program have achieved the intended goals.

We are revising the information collection to continue the Program and these assessments under the “PDUFA VII Commitment Letter.” The goals letter includes the procedures, and commitments that apply to aspects of the human drug review program that are important for facilitating timely access to safe, effective, and innovative new medicines for patients. Several of these commitments aim to continue to enhance communication between FDA and sponsors during application review. FDA and sponsors interact in a variety of ways throughout application review. One such way is via a communication, called an information request (IR), sent to an applicant as the discipline review occurs. FDA uses IRs to request further information or clarification that is needed or would be helpful to allow completion of the discipline review. IRs may be in the form of letters, emails, or Faxes.

FDA is committed to assessing current practices of CDER, CBER, and sponsors in communicating through product quality IRs during application review and effectiveness of Four-Part Harmony. We will contract with an independent third party to conduct assessments intended to identify best practices and areas of improvement in communications between FDA review staff and sponsors through product quality IRs. To accomplish these goals, the contractor will separately engage both FDA staff and sponsors through contractor-led interviews. Given the volume of IRs and IR amendments, these interviews will focus on a sample of applications and their associated IRs. The contractor may also choose to leverage web-based surveys, in addition to interviews, to accomplish the goals of the assessment. The contractor will anonymize and aggregate sponsor and FDA responses before including them in an assessment report, which is required by the PDUFA VII Commitment Letter. FDA will publish the report on FDA’s website and in the Federal Register, for public comment.

This assessment, utilizing information collected through surveys and interviews with FDA and original NDA and BLA sponsors, will be of great interest to FDA’s stakeholders, including the regulated industry. Equally important, the assessment will be critical in helping FDA understand sponsor perspectives on what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement.

Per the commitment letter, FDA will select a contractor to design a sampling method, in accordance with the requirements in the statement of work, for identifying applications to be included in the assessment. The contractor will also prepare a protocol and script for scheduling and conducting interviews with sponsors associated with the sample applications. If the contractor determines a survey to be necessary, they will develop a web-based survey to deploy. The protocol will ensure that the contractor schedules and conducts interviews and deploys any survey in a timely, consistent manner using good interview and survey practices. The interview script will include open-ended questions aimed at obtaining a thorough understanding of applicants’ experiences and insights relevant to product quality IRs associated with their application under the Program. If deployed, the survey would include closed and/or open-ended questions with the same purpose.

The contractor will analyze interview (and survey, if deployed) responses to identify challenges with Four-Part Harmony and best practices for communication via product quality IRs. The contractor will also use the interview (and survey, if deployed) data to consider trends across IRs, compare IRs before and after implementation of Four-Part Harmony, and add context to the contractor’s review of the sample IRs, as well as any other data collected. The contractor will synthesize and interpret the results to develop a set of findings and recommendations for the Program to be included in a final assessment report. In turn, FDA will use the independent assessment findings and recommendations to:

    • determine the success of Four-Part Harmony in improving communications via product quality IRs;

    • determine whether and how to refine implementation of Four-Part Harmony during the remainder of PDUFA VII;

    • 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.

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

FDA uses product quality IRs to request further information or clarification needed for FDA’s assessment of identity, strength, quality, purity, sterility/microbial controls, or potency of drug substances or drug products. Ensuring that patients can have confidence in the safety and effectiveness of their medications is a longstanding priority for FDA. The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have worked to address this priority, in part, by performing Chemistry, Manufacturing, and Controls (CMC) and Current Good Manufacturing Practice (CGMP) reviews for CDER- and CBER-regulated products. It is during these reviews that CDER or CBER may issue a product quality, or CMC, IR. IRs from both CDER and CBER are expected to follow Four-Part Harmony in which reviewers are expected to communicate: (1) what was provided, (2) what is the issue or deficiency, (3) what is needed, and (4) why it is needed. The PDUFA VII Commitment Letter includes commitments for FDA to update and conduct training on existing policies and procedures (Manual of Policies and Procedures and Standard Operating Procedures and Policies) based on the four essential components.

3. Use of Improved Information Technology and Burden Reduction

The information collection will be undertaken over a one-year period during the contractor’s period of performance, estimated to be spring 2023-2025. Estimated participation times are based on similar interviews and surveys for similar assessments.

  • Sponsors will participate in interviews via teleconference. One to three sponsor representatives may participate in each interview. The time required to respond to requests for an interview and participate in the interview is estimated to be up to 90 minutes. Selection of sponsors will be based on the estimated 40 applications to be included in the assessment sample.

  • If the contractor decides to conduct a survey, sponsors will respond to surveys by completing a fillable form online. The time required to complete a survey is estimated to be 15 minutes or less. FDA’s contractor will manage the survey using Qualtrics or a similar tool.

4. Efforts to Identify Duplication and Use of Similar Information

We are unaware of duplicative information collection.

5. Impact on Small Businesses or Other Small Entities

The information collection poses no undue burden on small entities.

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 21, 2022 (87 FR 16006); no comments were received, however we have slightly increased our initial estimate to better align with the upcoming goals.

9. Explanation of Any Payment or Gift to Respondents

Respondents will not receive any payments or gifts for participating in this information collection.

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 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

Table 1.--Estimated Annual Reporting Burden1


No. of Respondents

No. of Responses per Respondent

Total Annual Responses

Average Burden per Response

Total Hours


120 (one to three per application)




(15 minutes)



120 (one to three per application)







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

We plan interviews with up to three sponsor representatives per each application in each interview under the Program. Sponsors will participate in interviews via teleconference. In addition, if the contractor decides to conduct a survey, sponsors will respond to surveys (one survey response per individual) by completing a fillable form online. We estimate that 120 applicant representatives will expend approximately 15 minutes to complete a survey, for a total of 30 annual burden hours. We further estimate that up to 120 applicant representatives (up to three sponsor representatives for each of up to 40 applications) will participate in the interviews each year and that each interview will last approximately 90 minutes, for a total of 180 burden hours. There will be no recordkeeping or third-party disclosure burdens for this information collection.

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 calculated a median figure representing a range of wages for NDA/BLA managers in the pharmaceutical industry. We 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


14. Annualized Cost to the Federal Government

This two-year independent assessment of product quality IRs encompasses several evaluation methodologies, including interviews and potential surveys with NDA/BLA sponsors. The interview and survey effort involves development of protocols and scripts, implementation of the interviews and surveys, and analysis of results to develop findings and recommendations about FDA-sponsor IR communications. The annualized cost to the Federal government is estimated to be $245,000, which is the total contractor cost, FDA oversight cost of the interview portion of the independent assessment project, and FDA reviewer cost of the interviews the contractor will conduct with FDA reviewers. There are no other costs to the Federal government for implementation. Note that the total value of the contract is up to $1,200,000.00, and the contractor will conduct other activities in addition to this information collection as part of the contract.

Table 2: Estimated Annual Burden to the Federal Government

Portion of Study

Total Burden Hours

Hourly Wage Rate

Total Costs

Survey and interview development (contractor)



(Assumes $150 per individual, for 2 individuals)


Survey and interview development oversight (contractor)




Survey and interview implementation and analysis (contractor)



(Assumes $150 per individual, for 2 individuals)


Survey and interview implementation and analysis oversight (contractor)




Oversight of contractor activities (FDA)




Participating in FDA reviewer interviews and surveys (FDA staff)






15. Explanation for Program Changes or Adjustments

Since last OMB review and approval of the information collection, we have adjusted our burden estimate to include the same number of respondents for surveys and interviews, resulting in 100 additional responses, but one fewer hour, annually.

16. Plans for Tabulation and Publication and Project Time Schedule

The PDUFA VII Commitment Letter requires FDA to publish the statement of work for the assessment contract in the Federal Register before the contract is awarded. Because the contract has not yet been awarded, FDA does not yet have a concrete timeline for information collection. The contract period of performance is expected to be 2023-2025. As required by the PDUFA VII Commitment Letter, FDA will publish a final report summarizing the results of the overall assessment on FDA’s website for public comment by June 30, 2025. FDA expects the bulk of information collection to take place in 2024. The contractor will present overall assessment results in a final report on FDA’s website.

The contractor will develop data collection and analysis plans to describe how they will use the data collected to generate meaningful assessment results. The contractor will conduct qualitative and quantitative analyses to describe the state of product quality IRs and characterize trends, answer the assessment questions, and develop findings and recommendations for FDA and industry audiences.

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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