Export Certificates for FDA Regulated Products

ICR 202208-0910-015

OMB: 0910-0498

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Justification for No Material/Nonsubstantive Change
2022-09-06
Supporting Statement A
2021-03-03
Supplementary Document
2020-09-16
ICR Details
0910-0498 202208-0910-015
Received in OIRA 202101-0910-012
HHS/FDA OC
Export Certificates for FDA Regulated Products
No material or nonsubstantive change to a currently approved collection   No
Regular 09/07/2022
  Requested Previously Approved
04/30/2024 04/30/2024
19,431 19,431
30,606 30,606
3,400,425 3,400,425

This information collection supports FDA's export certificate program established under authority of sections 801(e)(4) and 802 of the Federal, Food, Drug, and Cosmetic Act. Respondents to the collection are those seeking to obtain export certificates for FDA-regulated products. We have developed associated forms, and fees not to exceed $175 per certificate may apply.

US Code: 21 USC 381; 382 Name of Law: FFDCA; Imports/Exports; Exports of Unapproved Products
   PL: Pub.L. 116 - 136 3856 Name of Law: CARES Act
  
None

Not associated with rulemaking

  85 FR 83091 12/21/2020
85 FR 83091 12/21/2020
No

  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 19,431 19,431 0 0 0 0
Annual Time Burden (Hours) 30,606 30,606 0 0 0 0
Annual Cost Burden (Dollars) 3,400,425 3,400,425 0 0 0 0
No
No

$0
No
    No
    No
No
No
No
Yes
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

  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.
09/07/2022


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