Request for Samples and Protocols

ICR 202108-0910-006

OMB: 0910-0206

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2021-08-27
ICR Details
0910-0206 202108-0910-006
Received in OIRA 201808-0910-009
HHS/FDA CBER
Request for Samples and Protocols
Extension without change of a currently approved collection   No
Regular 08/27/2021
  Requested Previously Approved
36 Months From Approved 09/30/2021
5,988 6,479
17,993 19,456
0 0

This information collection supports FDA regulations regarding the submission of biologic samples and protocols. The use of product sampling helps ensure the safety of these products and better enables FDA to fulfill its mission to protect the public health.

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 21 USC 301 et. seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  86 FR 14448 03/16/2021
86 FR 41488 08/02/2021
No

  Total Request 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 5,988 6,479 0 0 -491 0
Annual Time Burden (Hours) 17,993 19,456 0 0 -1,463 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$988,020
No
    No
    No
No
No
No
No
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.
08/27/2021


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