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

ICR 199910-0910-010

OMB: 0910-0430

Federal Form Document

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ICR Details
0910-0430 199910-0910-010
Historical Active
HHS/FDA
Guidance for Industry on Formal Dispute Resolutions; Appeal Above the Division Level
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/21/1999
Retrieve Notice of Action (NOA) 10/28/1999
  Inventory as of this Action Requested Previously Approved
02/28/2003 02/28/2003
64 0 0
512 0 0
0 0 0

FDA is issuing a draft guidance on the process for formally resolving scientific and procedural disputes in CDER and CBER that cannot be resolved at the division level. The draft guidance describes procedures for formally appealing such disputes to the office or center level and for submitting information to assist center officials in resolving the issue(s) presented. The draft guidance provides information on how the Agency will interpret and apply provisions of the existing regulations regarding internal Agency review of decisions (sections 10.75) and dispute resoluton during the IND....

None
None


No

1
IC Title Form No. Form Name
Guidance for Industry on Formal Dispute Resolutions; Appeal Above the Division Level 1571, 356H

  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 64 0 0 64 0 0
Annual Time Burden (Hours) 512 0 0 512 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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:
 
 
 
 
 
 
 
    (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.
10/28/1999


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