Orphan Drugs

ICR 202504-0910-005

OMB: 0910-0167

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2025-04-15
Supporting Statement A
2023-12-19
IC Document Collections
IC ID
Document
Title
Status
5770 Modified
ICR Details
0910-0167 202504-0910-005
Received in OIRA 202312-0910-005
HHS/FDA OC
Orphan Drugs
No material or nonsubstantive change to a currently approved collection   No
Regular 05/05/2025
  Requested Previously Approved
01/31/2027 01/31/2027
5,613 5,613
174,289 174,289
0 0

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.

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
  
None

Not associated with rulemaking

  88 FR 38513 06/13/2023
88 FR 84148 12/04/2023
Yes

1
IC Title Form No. Form Name
Orphan Drug Requirements FDA 4035 FDA Orphan Drug Designation Request Form

  Total Request 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
No
No
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.

$2,750,000
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/05/2025


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