Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act
Surveys and Interviews with
Investigational New Drug Sponsors to Assess Current Communication
Practices with FDA Review Staff Under the Sixth Authorization of
the Prescription Drug User Fee Act
New
collection (Request for a new OMB Control Number)
The Investigational New Drug (IND)
phase of drug development is the time during which human trials of
investigational drugs are conducted. During this time, IND sponsors
and FDA review staff communicate about IND status, questions, and
concerns. For the sixth authorization of the Prescription Drug User
Fee Act (PDUFA VI), the U.S. Food and Drug Administration (FDA)
committed to contracting with an independent third party to assess
current practices of FDA and sponsors in communicating during IND
drug development and identify best practices and areas of
improvement. To that end, the third-party contractor selected,
Eastern Research Group, Inc. (ERG), will collect data for a sample
of up to 150 active commercial INDs that have activity during a
one-year period. ERG will do so by collecting data on the INDs
themselves, conducting surveys and interviews with IND sponsors to
learn about their experiences, and obtain feedback from FDA
reviewer staff. The purpose of this information collection is to
understand active commercial IND sponsor perspectives on their
communications with FDA review staff. This includes perspectives on
what is working well, ongoing challenges and pain points, lessons
learned, and opportunities for improvement. The contractor will
develop anonymized aggregated summaries of survey and interview
responses, analyze this information to identify common themes,
consider these results along with IND data and feedback from FDA
review staff to develop a set of findings and recommendations, and
prepare a report and presentation. FDA will publish the report on
the Agency’s public website and hold a public meeting about the
assessment. The contractor will keep information collected private;
ERG will not disclose personally identifying information to FDA or
any other party.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Supporting Statement Part A PDUFA VI IND Communications 2018.docx
Investigational New Drug Sponsors: Interviews