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

ICR 202312-0910-001

OMB: 0910-0052

Federal Form Document

Forms and Documents
ICR Details
0910-0052 202312-0910-001
Received in OIRA 202106-0910-001
HHS/FDA CBER
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 06/28/2024
  Requested Previously Approved
36 Months From Approved 07/31/2024
2,722 2,966
1,460 1,496
0 0

The information collection supports statutory requirements under the Federal Food, Drug, and Cosmetic Act governing the registration of blood establishments and the listing of blood products. The information obtained through this collection registration assists FDA with its mandate to inspect facilities and helps to ensure protection of the public health and 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

  89 FR 17856 03/12/2024
89 FR 52063 06/21/2024
No

3
IC Title Form No. Form Name
Annual review and product listing update of registration
Initial registration
Waiver requests

  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 2,722 2,966 0 0 -244 0
Annual Time Burden (Hours) 1,460 1,496 0 0 -36 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects agency adjustments. We have adjusted the currently approved burden estimate we attribute to establishment registration and product listing to reflect a decrease in product listing updates and an increase in the number of initial registrations. Our estimated burden for the information collection reflects an overall decrease of 36 hours.

$126,949
No
    No
    No
No
No
No
No
Rachel Showalter 202 693-2146 [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.
06/28/2024


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