Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule

ICR 201506-0910-006

OMB: 0910-0795

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-06-03
IC Document Collections
IC ID
Document
Title
Status
216838
New
183146
Modified
183145
Modified
183144
Modified
183143
Modified
183142
Modified
183141
Modified
183140
Modified
183139
Modified
183138
Modified
183137
Modified
ICR Details
0910-0795 201506-0910-006
Historical Active 200712-0910-012
HHS/FDA CBER
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use - Final Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/02/2015
Retrieve Notice of Action (NOA) 06/03/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved
42,015,728 0 0
7,141,333 0 0
0 0 0

This information collection requires recordkeeping from establishments that collect blood and blood components and transfusion services to establish and maintain procedures and records for donors and the collection, processing, testing, storage, and distribution of blood and blood components. This information also requires notification to certain blood collection establishments concerning bacterial contamination of platelets. The information collection required by these regulations would be used by the collecting establishment to help ensure that a donor of blood and blood components is free of infectious disease, in good health, and eligible to donate without adversely affecting the health of the donor. In addition, the information collection would be used by the collecting establishment to determine that donations are suitable for transfusion or further manufacture.

US Code: 42 USC 262 Name of Law: Public Health Service Act
   US Code: 42 USC 264 Name of Law: Public Health Service Act
   US Code: 21 USC 321 Name of Law: Federal Food, Drug, and Cosmetic Act
  
Statute at Large: 21 Stat. 606 Name of Statute: null
Statute at Large: 21 Stat. 630 Name of Statute: null
Statute at Large: 21 Stat. 640 Name of Statute: null

0910-AG87 Final or interim final rulemaking 80 FR 29842 05/22/2015

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 42,015,728 0 3,087,563 38,928,165 0 0
Annual Time Burden (Hours) 7,141,333 0 1,127,850 6,013,483 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
Yes
Changing Regulations
This is a new information collection.

$2,548,800
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
06/03/2015


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