Orphan Drugs

Forms and Documents

Document	Type	Status	Availability
Form FDA 4035 FDA Orphan Drug Designation Request Form	Form and Instruction	Modified	Repair queued
83C_0167_Executive Order 14168_Form FDA 4035.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-15	Available
83C_0167_Executive Order 14168_Form FDA 4035.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2025-04-15	Repair queued
0167 Orphan Drugs Part 316 SSA 2023.docx	Supporting Statement A	Uploaded 2023-12-19	Available
0167 Orphan Drugs Part 316 SSA 2023.docx	Supporting Statement A	Uploaded 2023-12-19	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5770	Orphan Drug Requirements	Form and Instruction	Modified	FDA Orphan Drug Designation Request Form
5770	Orphan Drug Requirements	Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0167	ICR Reference No: 202504-0910-005
Status: Active	Previous ICR Reference No: 202312-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Orphan Drugs
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/06/2025
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/05/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2027	01/31/2027	01/31/2027
Responses	5,613	0	5,613
Time Burden (Hours)	174,289	0	174,289
Cost Burden (Dollars)	0	0	0

---

Abstract: This information is required to support implementation and administration of the Orphan Drug Act and FDA regulations found in 21 CFR part 316. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the applicable statutes and regulations.

---

Authorizing Statute(s): US Code: 21 USC 360bb Name of Law: FFDCA
   US Code: 21 USC 360cc Name of Law: FFDCA
   US Code: 21 USC 360aa Name of Law: FFDCA
   US Code: 21 USC 360dd Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 38513	06/13/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 84148	12/04/2023
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Orphan Drug Requirements	FDA 4035	FDA Orphan Drug Designation Request Form

---

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	5,613	5,613	0	0	0	0
Annual Time Burden (Hours)	174,289	174,289	0	0	0	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: We have adjusted our burden estimate to reflect an overall increase of 50,616 hours and 1,036 records annually. We attribute the adjustment to an increase in the number of submissions, amendments, and annual reports, as well as a comprehensive evaluation of the information collection.

---

Annual Cost to Federal Government: $2,750,000

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? No

---

Common Form ICR:  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:

(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: 05/05/2025

---