Formal Meetings with Sponsors and Applicants for PDUFA Products

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6097	CDER - Meeting Requests		Modified
189764	CBER - Information Packages		Modified
189763	CDER - Information Packages		Modified
189762	CBER- Meeting Requests		Modified

ICR Details

OMB Control No: 0910-0429	ICR Reference No: 202002-0910-002
Status: Active	Previous ICR Reference No: 201510-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Formal Meetings with Sponsors and Applicants for PDUFA Products
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/04/2020
	Date Received in OIRA: 02/13/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved
Responses	6,153	0	0
Time Burden (Hours)	83,386	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supplements FDA regulations by providing recommendations to industry on what to include in formal meeting requests between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by FDA.

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Authorizing Statute(s): US Code: 21 USC 360bbb Name of Law: FFDCA; General Provisions Relating to Drugs
  

Citations for New Statutory Requirements: PL: Pub.L. 115 - 52 601-611 Name of Law: FDARA of 2017; Improvements Related to Drugs

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 13130	07/11/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 71430	12/27/2019
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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	6,153	0	0	0	6,153	0
Annual Time Burden (Hours)	83,386	0	0	0	83,386	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: The information collection is being reinstated with change. We have revised the guidance document to include relevant discussion of updated performance goals under the FDARA of 2017. Although it currently remains a draft, we ultimately intend to finalize the guidance. We have also made adjustments to the annual burden hours and responses, which reflect an increase of 83,386 and 6,153 respectively. We attribute the adjustment to an increase in meeting requests and packages associated with our PDUFA program.

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Annual Cost to Federal Government: $0

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

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.     Yes

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: 02/13/2020

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