Orphan Drugs

Forms and Documents

Document Name	Status
Form Form 3671 Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	Removed
0167 ss 12-2020 final.pdf Supporting Statement A	2020-12-29

IC Document Collections

IC ID	Document Title	Status
5770	Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests Other-Guidance	Modified
213525	Deficiency letters and granting orphan-drug designation	Removed
212826	Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	Removed
181018	Insufficient quantities of orphan drugs	Removed
181017	Annual reports of holder of orphan drug designation	Removed
181016	Changes in ownership of orphan drug designation	Removed
181015	Permanent resident agent for foreign sponsor	Removed
181014	Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation	Removed

ICR Details

OMB Control No: 0910-0167	ICR Reference No: 202011-0910-012
Status: Received in OIRA	Previous ICR Reference No: 201711-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Orphan Drugs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/29/2020

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2021
Responses	4,577	2,144
Time Burden (Hours)	123,673	106,407
Cost Burden (Dollars)	0	0

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Abstract: This information is required in the implementation and administration of the Orphan Drug Act, 21 U.S.C., Sections 526-528. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the statute and regulations.

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

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:
	85 FR 62306	10/02/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 83971	12/23/2020
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
Orphan Drug Designation: requests content and format; notifications of changes; deficiency letters; annual reports; assurance of sufficient quantities; meeting requests	FDA 4035	FDA Orphan Drug Designation Request Form
Permanent resident agent for foreign sponsor
Changes in ownership of orphan drug designation
Annual reports of holder of orphan drug designation
Common European Medicines Agency/Food and Drug Administration Application Form	Form 3671, Form 4035	Common EMEA/FDA Application for Orphan Medicinal Product Designation ,   FDA Application for Orphan Medicinal Product Designation
Deficiency letters and granting orphan-drug designation
Insufficient quantities of orphan drugs
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation

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ICR Summary of Burden

	Total Request	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	4,577	2,144	0	4,576	-2,143	0
Annual Time Burden (Hours)	123,673	106,407	0	123,623	-106,357	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: The total number of requests for orphan designation have increased as a result of increased interest by the public and pharmaceutical industry in developing products for people with rare diseases and conditions. The burden was adjusted to reflect this increase. Since there is an increase of applications, sponsors who request a designation from only the FDA have the option of submitting the FDA Orphan Drug Designation Request Form (FDA Form 4035). The estimated annual hourly burden, formerly estimated as 106,407 hours, has increased by 8,250 hours to a total estimated annual hourly burden of 114,657 hours. We are consolidating into this request for approval 0910-0787, “Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development” which represents an additional increase in total burden hours of 9,016 hours. Therefore, the increase in total burden hours is 17,266. For the purpose of ease of entry in ROCIS the previously entered eight ICs was reduced to one IC.

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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.     No

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

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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: 12/29/2020

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