Orphan Products Development; Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation and FDA Orphan Drug Designation Request Form

Forms and Documents

Document Name	Status
Form Form 3671 Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	Modified
0167_Supporting_Statement_ 2017.docx Supporting Statement A	2017-12-19

IC Document Collections

IC ID	Document Title	Status
5770	Written recommendations; content and format of a request, the providing of; refusal to provide	Modified
213525	Deficiency letters and granting orphan-drug designation	Modified
212826	Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	Modified
181018	Insufficient quantities of orphan drugs	Modified
181017	Annual reports of holder of orphan drug designation	Modified
181016	Changes in ownership of orphan drug designation	Modified
181015	Permanent resident agent for foreign sponsor	Modified
181014	Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation	Modified

ICR Details

OMB Control No: 0910-0167	ICR Reference No: 201711-0910-007
Status: Active	Previous ICR Reference No: 201408-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Orphan Products Development; Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation and FDA Orphan Drug Designation Request Form
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: 01/31/2018
	Date Received in OIRA: 12/19/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2021	36 Months From Approved	01/31/2018
Responses	2,144	0	1,176
Time Burden (Hours)	106,407	0	76,255
Cost Burden (Dollars)	0	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 360cc Name of Law: FFDCA
   US Code: 21 USC 360bb 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:
	82 FR 27836	06/19/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 58424	12/12/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Written recommendations; content and format of a request, the providing of; refusal to provide
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Permanent resident agent for foreign sponsor
Changes in ownership of orphan drug designation
Annual reports of holder of orphan drug designation
Insufficient quantities of orphan drugs
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

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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	2,144	1,176	0	0	968	0
Annual Time Burden (Hours)	106,407	76,255	0	0	30,152	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:

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Annual Cost to Federal Government: $1,520,000

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? 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: 12/19/2017

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