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
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.