View Information Collection Request (ICR) Package
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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:
202504-0910-005
Status:
Active
Previous ICR Reference No:
202312-0910-005
Agency/Subagency:
HHS/FDA
Agency Tracking No:
OC
Title:
Orphan Drugs
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/06/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/05/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2027
01/31/2027
01/31/2027
Responses
5,613
0
5,613
Time Burden (Hours)
174,289
0
174,289
Cost Burden (Dollars)
0
0
0
Abstract:
This information is required to support implementation and administration of the Orphan Drug Act and FDA regulations found in 21 CFR part 316. The information is necessary to show that applicants qualify and continue to qualify for the incentives and assistance provided by the applicable statutes and regulations.
Authorizing Statute(s):
US Code:
21 USC 360bb
Name of Law: FFDCA
US Code:
21 USC 360cc
Name of Law: FFDCA
US Code:
21 USC 360aa
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:
88 FR 38513
06/13/2023
30-day Notice:
Federal Register Citation:
Citation Date:
88 FR 84148
12/04/2023
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Orphan Drug Requirements
FDA 4035
FDA Orphan Drug Designation Request Form
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
5,613
5,613
0
0
0
0
Annual Time Burden (Hours)
174,289
174,289
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
We have adjusted our burden estimate to reflect an overall increase of 50,616 hours and 1,036 records annually. We attribute the adjustment to an increase in the number of submissions, amendments, and annual reports, as well as a comprehensive evaluation of the information collection.
Annual Cost to Federal Government:
$2,750,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
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:
05/05/2025
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