Importation of Prescription Drugs

ICR 202006-0910-007

OMB: 0910-0888

Federal Form Document

Forms and Documents
ICR Details
0910-0888 202006-0910-007
Historical Inactive
HHS/FDA CDER
Importation of Prescription Drugs
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 06/12/2020
Retrieve Notice of Action (NOA) 06/11/2020
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 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 Proposed rulemaking 84 FR 70797 12/23/2019

No

No
No
ICR is establishing scope of information collection for proposed regulations in 21 CFR part 251 implementing section 804 of the Federal Food, Drug, and Cosmetic Act.

$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.
06/11/2020


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