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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
Abstract:
This collection of information describes procedures for requesting, scheduling, conducting, and documenting formal meetings.
Authorizing Statute(s):
US Code:
21 USC 312
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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.
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
Agency Contact:
Eliazabeth Berbakos 3018271482
Common Form ICR:
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:
(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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