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

ICR 201804-0910-015

OMB: 0910-0052

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2018-04-17
ICR Details
0910-0052 201804-0910-015
Active 201612-0910-006
HHS/FDA CBER
Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
Extension without change of a currently approved collection   No
Regular
Approved without change 06/25/2018
Retrieve Notice of Action (NOA) 04/17/2018
  Inventory as of this Action Requested Previously Approved
06/30/2021 36 Months From Approved 06/30/2018
2,952 0 2,708
1,496 0 1,401
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 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 42 USC 262 Name of Law: Public Health Service Act; Regulation of biological products
  
None

Not associated with rulemaking

  82 FR 61013 12/26/2017
83 FR 15148 04/09/2018
No

3
IC Title Form No. Form Name
Annual review and product listing update of registration
Waiver requests Form FDA 2830 Blood Establishment Registration and Product Listing
Initial registration

  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 2,952 2,708 0 0 244 0
Annual Time Burden (Hours) 1,496 1,401 0 0 95 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$142,500
No
    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.
04/17/2018


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