Assessment of Combination Product Review Practices

ICR 201902-0910-006

OMB: 0910-0868

Federal Form Document

IC Document Collections
IC ID
Document
Title
Status
234916 New
234915 New
ICR Details
0910-0868 201902-0910-006
Active
HHS/FDA CDER
Assessment of Combination Product Review Practices
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/15/2019
Retrieve Notice of Action (NOA) 02/14/2019
Approved with the understanding that any changes made as a result of pre-testing will be submitted for review and approval prior to full-scale data collection.
  Inventory as of this Action Requested Previously Approved
03/31/2022 36 Months From Approved
344 0 0
517 0 0
0 0 0

As part of the sixth authorization of the Prescription Drug User Fee Act, the U.S. Food and Drug Administration (FDA) committed to a third-party assessment of current combination product review practices, to include an information collection through engagement of FDA staff and individual sponsors of combination products. FDA has enlisted an independent contractor, Eastern Research Group, Inc. (ERG) for this purpose. The contractor proposes to conduct interviews with combination product sponsors and applicants to understand their perspectives on what is working well, challenges and pain points, lessons learned, and opportunities for improvement in submissions and reviews. The contractor will develop anonymized aggregated summaries of interview responses, analyze this information to identify common themes, consider these results along with submission data and feedback from FDA reviewers to develop a set of findings and recommendations, and prepare an assessment report for publication on the Agency’s public website.

None
None

Not associated with rulemaking

  83 FR 48822 09/27/2018
84 FR 3459 02/12/2019
No

2
IC Title Form No. Form Name
Pre-Test
Interviews

  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 344 0 0 344 0 0
Annual Time Burden (Hours) 517 0 0 517 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$135,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  No

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.
02/14/2019


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