Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0429 10-9-2015.doc Supporting Statement A	2015-10-19

IC Document Collections

IC ID	Document Title	Status
6097	CDER - Meeting Requests Other-Guidance	Modified
189764	CBER - Information Packages Other-Guidance	Modified
189763	CDER - Information Packages Other-Guidance	Modified
189762	CBER- Meeting Requests Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0429	ICR Reference No: 201510-0910-004
Status: Historical Active	Previous ICR Reference No: 201207-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/31/2015
	Date Received in OIRA: 10/21/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	4,728	0	3,864
Time Burden (Hours)	64,088	0	51,416
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance describes the procedures for requesting, scheduling, conducting, and documenting formal meetings with applicants and sponsors, including the submission of a meeting request and the submission of an information package in advance of the formal meeting.

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Authorizing Statute(s): US Code: 21 USC 312 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	80 FR 29010	05/20/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 60913	10/08/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
CDER - Meeting Requests
CBER- Meeting Requests
CDER - Information Packages
CBER - Information Packages

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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	4,728	3,864	0	0	864	0
Annual Time Burden (Hours)	64,088	51,416	0	0	12,672	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: We have adjusted the approved burden of 51,416 hours based on actual submissions received under the guidance during the past 3 years. The new burden is 63,992 hours.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 10/21/2015

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