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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3671 Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)	Form and Instruction	Removed	Available
0167 ss 4-8-11.doc	Supporting Statement A	Uploaded 2011-04-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5770	Written recommendations: content and format of a request; the Providing of; Refusal to Provide		Modified
182669	Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)	Form and Instruction	Removed
181018	Insufficient quantities of orphan drugs		Modified
181017	Annual reports of holder of orphan drug designation		Modified
181016	Changes in ownershiop 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: 201105-0910-005
Status: Historical Inactive	Previous ICR Reference No: 200805-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 06/27/2011
	Date Received in OIRA: 05/19/2011
Terms of Clearance: In accordance with 5 CFR 1320, OMB considers this ICR to be improperly submitted. It was submitted as an extension but the data indicate that there has been a burden increase due to agency discretion. Please resolve this discrepancy and resubmit this request to OMB.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	10/31/2011
Responses	943	0	943
Time Burden (Hours)	47,565	0	47,565
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 360dd Name of Law: FFDCA
   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
  

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:
	76 FR 3910	01/21/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 27328	05/11/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Permanent resident agent for foreign sponsor
Changes in ownershiop of orphan drug designation
Annual reports of holder of orphan drug designation
Insufficient quantities of orphan drugs
Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)	FDA 3671	COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION
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

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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: Refer to Part II IC changes

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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: 05/19/2011

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