Orphan Drug Products

Forms and Documents

Document Name	Status
Form FDA 3671 Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671) Form and Instruction	New
0167 amendment CoverMemotoOMB 2007.doc Supplementary Document	2007-11-06
EMEA Supporting Statement 11-1-07.doc Supporting Statement A	2007-11-06

IC Document Collections

IC ID	Document Title	Status
5770	Orphan Drug Products	Modified
182669	Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671) Form and Instruction	New
181018	Orphan Drug Products	Modified
181017	Orphan Drug Products	Modified
181016	Orphan Drug Products	Modified
181015	Orphan Drug Products	Modified
181014	Orphan Drug Products	Modified

ICR Details

OMB Control No: 0910-0167	ICR Reference No: 200711-0910-001
Status: Historical Active	Previous ICR Reference No: 200707-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Orphan Drug Products
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: 11/13/2007
	Date Received in OIRA: 11/09/2007
Terms of Clearance: This information collection request (ICR) is approved, as requested for a period of 6 months. The approval period is abbreviated because the revision request did not go through the full public comment (60 day + 30 day). FDA will resubmit this collection prior to expiration, following the standard PRA procedures.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2008	36 Months From Approved	08/31/2010
Responses	943	0	903
Time Burden (Hours)	47,565	0	46,285
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 360bb Name of Law: FFDCA
   US Code: 21 USC 360aa 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:
	71 FR 63325	10/30/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 63635	11/09/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Orphan Drug Products
Orphan Drug Products
Orphan Drug Products
Orphan Drug Products
Orphan Drug Products
Orphan Drug Products
Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)	FDA 3671	COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT 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	943	903	0	40	0	0
Annual Time Burden (Hours)	47,565	46,285	0	1,280	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: No

Burden Reduction Due to:

Short Statement: Based on the increased number of requests for orphan product designations over the past three years, FDA increased the number of respondents for this collection of information resulting in a total burden increase of 8,942 hours.

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Annual Cost to Federal Government: $450,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 11/09/2007

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