Export Notification and Recordkeeping Requirements

ICR 201811-0910-004

OMB: 0910-0482

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-06-03
ICR Details
0910-0482 201811-0910-004
Active 201601-0910-011
HHS/FDA ORA
Export Notification and Recordkeeping Requirements
Extension without change of a currently approved collection   No
Regular
Approved without change 07/01/2019
Retrieve Notice of Action (NOA) 06/05/2019
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 06/30/2019
3,635 0 12,239
69,330 0 198,873
363,500 0 0

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

  84 FR 4473 02/15/2019
84 FR 23055 05/21/2019
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 3,635 12,239 0 0 -8,604 0
Annual Time Burden (Hours) 69,330 198,873 0 0 -129,543 0
Annual Cost Burden (Dollars) 363,500 0 0 0 363,500 0
No
No
The information collection reflects adjustments in our estimated burden. Cumulatively these adjustments result in an overall reduction to the information collection by 8,604 annual responses and 129,543 burden hours.

$168,882
No
    No
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.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.
06/05/2019


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