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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Statement Part A PDUFA VI IND Communications 2018.docx	Supporting Statement A	Uploaded 2018-11-16	Available
Survey Protocol.docx	Supplementary Document	Uploaded 2018-11-16	Available
Interview Protocol.docx	Supplementary Document	Uploaded 2018-11-16	Available
Interview Script.docx	Supplementary Document	Uploaded 2018-11-16	Available
Supporting Statement Part B PDUFA VI IND Communications 2018.docx	Supporting Statement B	Uploaded 2018-11-16	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
233950	Investigational New Drug Sponsors: Interviews	Other-Survey	New
233949	Investigational New Drug Sponsors: Surveys	Other-Survey	New

ICR Details

OMB Control No: 0910-0863	ICR Reference No: 201811-0910-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: 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
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/14/2018
	Date Received in OIRA: 11/19/2018
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved
Responses	600	0	0
Time Burden (Hours)	701	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 40771	08/16/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 56349	11/13/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Investigational New Drug Sponsors: Surveys
Investigational New Drug Sponsors: Interviews

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	600	0	0	600	0	0
Annual Time Burden (Hours)	701	0	0	701	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $150,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/19/2018

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