Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

ICR 201612-0910-006

OMB: 0910-0052

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2016-12-13
IC Document Collections
ICR Details
0910-0052 201612-0910-006
Historical Active 201501-0910-007
HHS/FDA CBER
Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Revision of a currently approved collection   No
Regular
Approved without change 12/29/2016
Retrieve Notice of Action (NOA) 12/16/2016
  Inventory as of this Action Requested Previously Approved
05/31/2018 36 Months From Approved 05/31/2018
2,708 0 2,849
1,401 0 1,418
0 0 0

The information collection supports agency requirements regarding the registration of blood establishments and the listing of blood products. The information obtained through the registration and product listing of domestic and foreign blood establishments assists FDA in its inspections of facilities. This information is essential to the overall regulatory scheme designed to ensure the safety of the nation's blood supply.

US Code: 21 USC 360 Name of Law: FD&C Act
  
PL: Pub.L. 110 - 85 224 Name of Law: FDA Amendments Act; Electronic Registration and Listinng

0910-AA49 Final or interim final rulemaking 81 FR 60170 08/31/2016

  71 FR 51276 08/29/2006
81 FR 60170 08/31/2016
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 2,708 2,849 -141 0 0 0
Annual Time Burden (Hours) 1,401 1,418 -17 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$140,828
No
No
No
No
No
Uncollected
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.
12/16/2016


© 2024 OMB.report | Privacy Policy