Importation of Prescription Drugs

ICR 202010-0910-005

OMB: 0910-0888

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-10-01
Supplementary Document
2020-10-01
IC Document Collections
ICR Details
0910-0888 202010-0910-005
Active 202006-0910-007
HHS/FDA CDER
Importation of Prescription Drugs
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 10/09/2020
Retrieve Notice of Action (NOA) 10/01/2020
  Inventory as of this Action Requested Previously Approved
10/31/2023 36 Months From Approved
100 0 0
6,040 0 0
0 0 0

This ICR collects information from Section 804 Importation Programs (SIPs), which would be authorized by FDA and overseen by States or certain other governmental entities (SIP Sponsors) that seek to import certain prescription drugs from Canada.

US Code: 21 USC 384 Name of Law: FFDCA; Importation of Prescription Drugs
  
None

0910-AI45 Final or interim final rulemaking 85 FR 62094 10/01/2020

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 100 0 0 0 100 0
Annual Time Burden (Hours) 6,040 0 0 -360 6,400 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    Yes
    No
No
No
No
No
Domini Bean 301 796-5733 domini.bean@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.
10/01/2020


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