This information
collection is approved through 12/85 to allow FDA time to complete
the rulemaking procedure required by the 111/26/84 letter from
James B. MacRae Jr. to Wallace Keene, Acting Deputy Assistant
Secretary.
Inventory as of this Action
Requested
Previously Approved
12/31/1985
12/31/1985
08/31/1984
2,060
0
2,060
3,000,000
0
3,000,040
0
0
0
THE GOOD MANUFACTURING PRACTICES
REGULATIONS FOR THE COLLECTION, PROCESSING, AND STORAGE OF BLOOD
AND BLOOD COMPONENTS ARE INTENDED TO MINIMIZE THE DANGERS OF
HEPATITIS IN BLOOD-BASED THERAPY AND TO ASSURE THE PRODUCTION OF
BLOOD AND BLOOD COMPONENTS OF UNIFORM HIGH QUALITY.
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.