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

ICR 200712-0910-012

OMB: 0910-0795

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2007-11-14
Supplementary Document
2007-11-14
Supplementary Document
2007-11-14
Supplementary Document
2007-11-14
Supporting Statement A
2007-11-23
ICR Details
0910-0795 200712-0910-012
Historical Inactive
HHS/FDA
Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 06/02/2015
Retrieve Notice of Action (NOA) 12/20/2007
The information collection requirements associated with this proposed rule are not approved at this time. FDA will consider comments received and resubmit at the final rule stage.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

Blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351 of the PHS Act, which requires that such products be licensed. To obtain a license, applicants must show that the collecting establishment meets all applicable standards designed to assure the continued safety, purity, and potency of the blood and blood components, and that the product is safe, pure, and potent. FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring collecting establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.

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. 640 Name of Statute: null
Statute at Large: 21 Stat. 606 Name of Statute: null
Statute at Large: 21 Stat. 630 Name of Statute: null

0910-AG87 Proposed rulemaking 72 FR 63416 11/08/2007

No

No
No
FDA is taking this action to help ensure the safety of the national blood supply and to help protect donor health by requiring collecting establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process.

$0
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.
12/20/2007


© 2024 OMB.report | Privacy Policy