ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS, PROPOSED AMENDMENTS OF REQUIREMENTS FOR BLOOD GROUPING SERUM-NPRM

ICR 198503-0910-003

OMB: 0910-0209

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0209 198503-0910-003
Historical Active
HHS/FDA
ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS, PROPOSED AMENDMENTS OF REQUIREMENTS FOR BLOOD GROUPING SERUM-NPRM
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/02/1985
Retrieve Notice of Action (NOA) 03/06/1985
  Inventory as of this Action Requested Previously Approved
02/28/1988 02/28/1988
1 0 0
1 0 0
0 0 0

FDA IS PROPOSING TO AMEND ITS ADDITIONAL STANDARDS FOR BLOOD GROUPING SERUM IN RESPONSE TO PUBLIC COMMENTS DURING THE RETROSPECTIVE REVIEW OF THE REGULATION. FDA IS REDUCING BURDEN AND PROVIDING MORE FLEXIBILITY WITHOUT LOSS OF CONSUMER PROTECTION. AFFECTED PUBLIC: MANUFACTURERS AND DISTRIBUTORS OF BLOOD GROUPING SERUM.

None
None


No

  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 1 0 0 0 1 0
Annual Time Burden (Hours) 1 0 0 0 1 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
03/06/1985


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