Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802

ICR 201305-0910-001

OMB: 0910-0498

Federal Form Document

ICR Details
0910-0498 201305-0910-001
Historical Active 201210-0910-004
HHS/FDA 19441
Export Certificates for FDA Regulated Products under U.S.C. Sections 801(e) and 802
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved with change 05/20/2013
Retrieve Notice of Action (NOA) 05/08/2013
  Inventory as of this Action Requested Previously Approved
03/31/2015 03/31/2015 03/31/2015
78,343 0 78,343
50,942 0 50,942
3,107,462 0 3,107,462

Section 801(e)(4) of the act provides that persons exporting certain FDA-regulated products may request FDA to certify that the products meet the requirements of Sections 801(e) or 802 of the FD&C Act, or other requirements of the act. This section of the law requires FDA to issue export certificates within 20 days of receipt of the request and to charge firms up to $175 for the certificates.

US Code: 21 USC 381 Name of Law: FFDCA
   US Code: 21 USC 382 Name of Law: FFDCA
  
None

Not associated with rulemaking

No

  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 78,343 78,343 0 0 0 0
Annual Time Burden (Hours) 50,942 50,942 0 0 0 0
Annual Cost Burden (Dollars) 3,107,462 3,107,462 0 0 0 0
No
No

$3,127,732
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
05/08/2013


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