Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level

ICR 200904-0910-011

OMB: 0910-0430

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0430 200904-0910-011
Historical Active 200602-0910-001
Guidance for Industry on Formal Dispute Resolutions; Appeals Above the Division Level
Extension without change of a currently approved collection   No
Approved with change 08/10/2009
Retrieve Notice of Action (NOA) 04/29/2009
This ICR is approved for 3 years. However, FDA is reminded that #13 of the supporting statement should reflect capital/maintenance costs, not the wage cost of reporting.
  Inventory as of this Action Requested Previously Approved
08/31/2012 36 Months From Approved 08/31/2009
23 0 11
184 0 88
0 0 0

This collection of information describes the process for formally reoslving scientific and procedural disputes in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) that cannot be resolved at the division level.

US Code: 21 USC 314.103 Name of Law: FFDCA
   US Code: 21 USC 312.48 Name of Law: FFDCA

Not associated with rulemaking

  73 FR 65385 11/03/2008
74 FR 19225 04/28/2009

  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 23 11 0 0 12 0
Annual Time Burden (Hours) 184 88 0 0 96 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Eliazabeth Berbakos 3018271482


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:
    (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;
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.

© 2024 | Privacy Policy