APPROVED FOR SIX
MONTHS. IN REVISING GMP REGULATIONS FOR BLOOD, FDA SHOULD EITHER
ADOPT EXISTING RECORDKEEPING REQUIREMENTS ADOPTED BY THE AMERICAN
ASSOCIATION OF BLOOD BANKS(AABB) OR EXEMPT AABB MEMBERS FROM THE
FDA REQUIREMENTS. ONLY BY CHOOSING ONE OF THESE ALTERNATIVES WILL
OMB CONSIDER FDA'S CORRECTION OF BURDEN AS VALID.
Inventory as of this Action
Requested
Previously Approved
11/30/1983
11/30/1983
03/31/1983
12,000,040
0
12,000,040
3,000,000
0
3,000,000
0
0
0
THE GMPS FOR BLOOD AND BLOOD
COMPONENTS PRESCRIBES CRITERIA FOR THE COLLECTION, PROCESSING, AND
STORAGE OF BLOOD AND BLOOD COMPONENTS INTENDED TO ASSURE THE
PRODUCTION OF BLOOD AND BLOOD COMPONENTS OF UNIFORM HIGH QUALITY,
AND TO MINIMIZE THE DANGERS OF HEPATITIS IN BLOOD-BASED
THERAPY.
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.