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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:
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
Retrieve Notice of Action (NOA)
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
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 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
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:
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
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
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.
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
Agency Contact:
Jonnalynn Capezzuto 3018274659
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:
11/09/2007
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