Orphan Drug Credit

ICR 201804-1545-020

OMB: 1545-1505

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2018-05-16
IC Document Collections
IC ID
Document
Title
Status
18532 Modified
ICR Details
1545-1505 201804-1545-020
Active 201504-1545-010
TREAS/IRS
Orphan Drug Credit
Revision of a currently approved collection   No
Regular
Approved without change 12/19/2018
Retrieve Notice of Action (NOA) 07/24/2018
  Inventory as of this Action Requested Previously Approved
12/31/2021 36 Months From Approved 12/31/2018
67 0 67
316 0 348
0 0 0

Filers use this form to elect to claim the orphan drug credit, which is 25% 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.

US Code: 26 USC 45C Name of Law: Clinical testing expenses for certain drugs for rare diseases or conditions
  
None

Not associated with rulemaking

  83 FR 12081 03/18/2018
83 FR 35056 07/24/2018
No

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

  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 67 67 0 0 0 0
Annual Time Burden (Hours) 316 348 0 0 -32 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The reduction in burden was achieved, due to the previous burden calculation was not based on the most current revision of form 8820 at that time, which reduced the burden hours by (32 hrs.) Also, we are making this submission to renew the OMB approval.

$50
No
    Yes
    No
No
No
No
Uncollected
K Slaton 2022832734

  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.
07/24/2018


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