Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

ICR 201807-0910-003

OMB: 0910-0594

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-07-05
IC Document Collections
IC ID
Document
Title
Status
43606 Modified
ICR Details
0910-0594 201807-0910-003
Active 201506-0910-020
HHS/FDA CBER
Guidance for Industry and FDA Staff; Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
Extension without change of a currently approved collection   No
Regular
Approved without change 08/17/2018
Retrieve Notice of Action (NOA) 07/16/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved 09/30/2018
3 0 4
15 0 20
0 0 0

This information collection supports Food and Drug Administration (FDA, us or we) regulations. Under the Safe Medical Devices Act of 1990 (Public Law 101 – 629), FDA may establish special controls, including performance standards, postmarket surveillance, patient registries, guidelines, and other appropriate actions it believes necessary to provide reasonable assurance of the safety and effectiveness of a device. The special controls guidance document entitled, “Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle,” serves as the special control for the automated blood cell separator device operating by centrifugal or filtration separation principle intended for the routine collection of blood and blood components, as codified under 21 CFR 864.9245.

US Code: 21 USC 360 Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 101 - 629 104 Name of Law: Safe Medical Devices Act of 1990
  
None

Not associated with rulemaking

  83 FR 7745 02/22/2018
83 FR 32883 07/16/2018
Yes

1
IC Title Form No. Form Name
Annual Report

  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 3 4 0 0 -1 0
Annual Time Burden (Hours) 15 20 0 0 -5 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$210
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 [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.
07/16/2018


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