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

ICR 201506-0910-019

OMB: 0910-0498

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2015-06-18
Justification for No Material/Nonsubstantive Change
2015-06-12
Supporting Statement A
2015-06-12
ICR Details
0910-0498 201506-0910-019
Historical Active 201506-0910-016
HHS/FDA OC
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 without change 06/22/2015
Retrieve Notice of Action (NOA) 06/18/2015
  Inventory as of this Action Requested Previously Approved
03/31/2018 03/31/2018 03/31/2018
19,712 0 19,712
35,491 0 35,491
3,226,433 0 3,226,433

Section 801(e)(4) of the Act provides that persons exporting certain FDA-regulated products may request that FDA certify that the products meet the requirements of sections 801(e) or 802 or other requirements of the Act. The Act does not require FDA to issue certificates for food, including animal feeds, food and feed additives, and dietary supplements, or cosmetics. However, since foreign governments may require certificates for these types of products, the agency intends to continue to provide this service as resources permit. Section 801(e)(4) of the Act also provides that FDA may charge a fee of up to $175 if FDA issues a certificate within 20 days of receipt of a complete request for such a certificate. This fee may vary depending on the product type, but it will not exceed $175.

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

Not associated with rulemaking

  79 FR 68277 11/14/2014
80 FR 6728 02/06/2015
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 19,712 19,712 0 0 0 0
Annual Time Burden (Hours) 35,491 35,491 0 0 0 0
Annual Cost Burden (Dollars) 3,226,433 3,226,433 0 0 0 0
No
No
Adding CDER back into this information collection.

$3,000,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
06/18/2015


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