Orphan Drug Credit

ICR 199611-1545-006

OMB: 1545-1505

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
18528 Migrated
ICR Details
1545-1505 199611-1545-006
Historical Active
TREAS/IRS
Orphan Drug Credit
New collection (Request for a new OMB Control Number)   No
Emergency 11/25/1996
Approved without change 11/25/1996
Retrieve Notice of Action (NOA) 11/18/1996
The agency is not required to display the expiration date.
  Inventory as of this Action Requested Previously Approved
05/31/1997 05/31/1997
20 0 0
169 0 0
0 0 0

Filers use this form to elect to claim the orphan drug credit, which is 50 percent of the qualified clinical testing expenses paid or incurred with respect to low or unprofitable drugs for rare diseases and conditions, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act.

None
None


No

1
IC Title Form No. Form Name
Orphan Drug Credit 8820

  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 20 0 0 20 0 0
Annual Time Burden (Hours) 169 0 0 169 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.
11/18/1996


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