Export Notification and Recordkeeping Requirements

ICR 202201-0910-009

OMB: 0910-0482

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-05-03
ICR Details
0910-0482 202201-0910-009
Received in OIRA 201811-0910-004
HHS/FDA CROSS CENTER
Export Notification and Recordkeeping Requirements
Extension without change of a currently approved collection   No
Regular 05/03/2022
  Requested Previously Approved
36 Months From Approved 07/31/2022
2,176 3,635
45,079 69,330
0 363,500

The information collection supports FDA regulations at 21 CFR 1.101 and pertains to the notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports under sections 801 or 802 of the Federal Food, Drug, and Cosmetic Act or (21 U.S.C. 381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262).

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301, et. seq. Name of Law: FFDCA
  
None

Not associated with rulemaking

  87 FR 3811 01/25/2022
87 FR 24321 04/25/2022
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 2,176 3,635 0 0 -1,459 0
Annual Time Burden (Hours) 45,079 69,330 0 0 -24,251 0
Annual Cost Burden (Dollars) 0 363,500 0 0 -363,500 0
No
No
Based on a review of Agency data, we decreased our estimate by 24,251 burden hours. This decrease reflects an overall downward trend in the number of export certification requests across programs and commodities. The estimate for tobacco products remains steady.

$111,368
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 [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.
05/03/2022


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