Orphan Drug Credit

Forms and Documents

Document Name	Status
Form 8820 Orhpan Drug Credit Form and Instruction	Modified
2018-05-15_SS_1545-1505r (002).doc Supporting Statement A	2018-05-16

IC Document Collections

IC ID	Document Title	Status
18532	Orhpan Drug Credit Form and Instruction	Modified

ICR Details

OMB Control No: 1545-1505	ICR Reference No: 201804-1545-020
Status: Active	Previous ICR Reference No: 201504-1545-010
Agency/Subagency: TREAS/IRS	Agency Tracking No:
Title: Orphan Drug Credit
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/19/2018
	Date Received in OIRA: 07/24/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2021	36 Months From Approved	12/31/2018
Responses	67	0	67
Time Burden (Hours)	316	0	348
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 26 USC 45C Name of Law: Clinical testing expenses for certain drugs for rare diseases or conditions
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 12081	03/18/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 35056	07/24/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $50

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 07/24/2018

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