Draft Guidance for Industry and FDA Staff-Class II Special Controls: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle
ICR 200908-0910-003
OMB: 0910-0594
Federal Form Document
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0594 can be found here:
Draft Guidance for Industry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
The draft guidance document serves as
the special control to support the reclassification from class III
to class II of the automated blood cell separator device operating
on a centrifugal or filtration separation principle intended for
the routine collection of blood and blood components.
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.