Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

ICR 201105-0910-005

OMB: 0910-0167

Federal Form Document

ICR Details
0910-0167 201105-0910-005
Historical Inactive 200805-0910-004
HHS/FDA
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
Extension without change of a currently approved collection   No
Regular
Improperly submitted and continue 06/27/2011
Retrieve Notice of Action (NOA) 05/19/2011
In accordance with 5 CFR 1320, OMB considers this ICR to be improperly submitted. It was submitted as an extension but the data indicate that there has been a burden increase due to agency discretion. Please resolve this discrepancy and resubmit this request to OMB.
  Inventory as of this Action Requested Previously Approved
06/30/2011 36 Months From Approved 10/31/2011
943 0 943
47,565 0 47,565
0 0 0

This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.

US Code: 21 USC 360dd Name of Law: FFDCA
   US Code: 21 USC 360bb Name of Law: FFDCA
   US Code: 21 USC 360aa Name of Law: FFDCA
   US Code: 21 USC 360cc Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 3910 01/21/2011
76 FR 27328 05/11/2011
No

Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
Refer to Part II IC changes

$566,625
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659

  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.
05/19/2011


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