[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52782-52784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0093]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Review Transparency 
and Communication for New Molecular Entity New Drug Applications and 
Original Biologics License Applications in Prescription Drug User Fee 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 28, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0746. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three

[[Page 52783]]

White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 
20852, 301-796-5733, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Review Transparency and Communication for New Molecular Entity New Drug 
Applications (NME NDA) and Original Biologics License Applications 
(BLAs) in Prescription Drug User Fee Submissions

OMB Control Number 0910-0746--Revision

    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.
    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 review teams 
have been effective in enhancing transparency and communication, with 
milestone meetings also enhancing the predictability of the review 
process. We have also adapted certain good practices, 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 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 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.
    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

[[Page 52784]]

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.
    In the Federal Register of March 21, 2022 (87 FR 16006), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received; however, we have 
slightly increased the estimate from our 60-day notice to fully align 
with planned program goals.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                    Number of
           Activity                Number of      responses per   Total annual    Average burden    Total hours
                                  respondents      respondent       responses     per  response
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Surveys......................  120 (one to                    1             120  0.25 (15                     30
                                three per                                         minutes).
                                application).
Interviews...................  120 (one to                    1             120  1.5............             180
                                three per
                                application).
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    Total....................  ................  ..............  ..............  ...............             210
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\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.

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18546 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P