Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form 3671)

Forms and Documents

Document Name	Status
Form Form 3671 Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	New
0167_Supporting_Statement10-16-2014.docx Supporting Statement A	2014-10-17

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	New
212826	Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction	New
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: 201408-0910-001
Status: Historical Active	Previous ICR Reference No: 201106-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form 3671)
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: 12/23/2014
	Date Received in OIRA: 10/27/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved	12/31/2014
Responses	1,176	0	2,183
Time Burden (Hours)	76,255	0	69,726
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:
	79 FR 21471	04/16/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 60474	10/07/2014
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	Common EMEA/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	1,176	2,183	0	-1,007	0	0
Annual Time Burden (Hours)	76,255	69,726	0	6,529	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The program change represents the consolidation of 0910-0702, a final rule that was submitted to and approved by OMB in 2013. This final rule incorporated two changes in the regulations and the addition of form FDA 3671.

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Annual Cost to Federal Government: $566,625

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 10/27/2014

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