Notice2022-18546
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
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Published
August 29, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 166 (Monday, August 29, 2022)</title>
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[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52782-52784]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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, <a href="/cdn-cgi/l/email-protection#09595b485a7d686f6f496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="3d6d6f7c6e495c5b5b7d5b595c1355554e135a524b">[email protected]</span></a>.
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: <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>.
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
<a href="https://www.fda.gov/media/144130/download">https://www.fda.gov/media/144130/download</a>. 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
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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:
<bullet> determine the success of Four-Part Harmony in improving
communications via product quality IRs;
<bullet> determine whether and how to refine implementation of
Four-Part Harmony during the remainder of PDUFA VII;
<bullet> demonstrate compliance with the commitment to conduct the
independent assessments
<bullet> and publish them for public comment; and
<bullet> 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
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