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

Forms and Documents

Document Name	Status
0429 supporting 3 2009.doc Supporting Statement A	2009-03-13

IC Document Collections

IC ID	Document Title	Status
6097	Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products	Modified
188614	Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products	New
188613	Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products	New
188612	Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products	New

ICR Details

OMB Control No: 0910-0429	ICR Reference No: 200903-0910-009
Status: Historical Inactive	Previous ICR Reference No: 200601-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 06/15/2009
	Date Received in OIRA: 03/31/2009
Terms of Clearance: Per FDA memo of 6/5/09, this ICR is being returned as "improperly submitted" because it should have come in as an "extension without change" rather than as a "revision." Upon resubmission, FDA agrees to clarify the nature of the burden changes in the supporting statement. If the burden changes are, in fact, adjustments to agency estimates of burden, the burden changes should be listed in the "adjustments" column rather than the "change due to agency discretion" column.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2009	36 Months From Approved	08/31/2009
Responses	3,642	0	3,642
Time Burden (Hours)	49,004	0	49,004
Cost Burden (Dollars)	0	0	0

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Abstract: This collection of information describes procedures for requesting, scheduling, conducting, and documenting formal meetings.

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Authorizing Statute(s): US Code: 21 USC 312 Name of Law: FFDCA
  

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:
	73 FR 67184	11/13/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 11114	03/16/2009
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
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products
Guidance for Industry on Formal Meetings with Sponsors and Applicants for PDUFA Products

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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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The change in burden is the result of submissions received under the guidance during the past 3 years.

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 03/31/2009

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