Assessment of Combination Product Review Practices

Forms and Documents

Document	Type	Status	Availability
Supporting Statement Part B Combination Product Review Practices 2018.docx	Supporting Statement B	Uploaded 2019-02-12	Available
Supporting Statement Part A Assessment of Combination Product Review Practices 2018.docx	Supporting Statement A	Uploaded 2019-02-12	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
234916	Interviews	Other-Survey Instrument	New
234915	Pre-Test	Other-Survey Instrument	New

ICR Details

OMB Control No: 0910-0868	ICR Reference No: 201902-0910-006
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Assessment of Combination Product Review Practices
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 without change	Conclusion Date: 03/15/2019
	Date Received in OIRA: 02/14/2019
Terms of Clearance: 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
Expiration Date	03/31/2022	36 Months From Approved
Responses	344	0	0
Time Burden (Hours)	517	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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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 48822	09/27/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 3459	02/12/2019
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Pre-Test
Interviews

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ICR Summary 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	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

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: $135,000

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: 02/14/2019

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