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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
8
IC Title
Form No.
Form Name
Annual reports of holder of orphan drug designation
Changes in ownership of orphan drug designation
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
Insufficient quantities of orphan drugs
Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation
Permanent resident agent for foreign sponsor
Written recommendations; content and format of a request, the providing of; refusal to provide
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.
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
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
No
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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