HUMAN TISSUE INTENDED FOR TRANSPLANTATION -- 21 CFR 1270

ICR 199403-0910-002

OMB: 0910-0302

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
110008
Migrated
ICR Details
0910-0302 199403-0910-002
Historical Active
HHS/FDA
HUMAN TISSUE INTENDED FOR TRANSPLANTATION -- 21 CFR 1270
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 06/08/1994
Retrieve Notice of Action (NOA) 03/11/1994
We have approved the information collection requirements contained in the interim final rule published on December 14, 1993 with the followi condition. We have approved the collection for less than the maximum three-year period allowed under the Paperwork Reduction Act because th interim final rule was promulgated without affording the public an opportunity to comment on the information collection requirements contained in the rule. In developing the proposed revisions to the interim final rule that it has promised, FDA should carefully consider the results of the tissue bank survey it is currently conducting. FDA should use the survey to assess the current voluntary industry standar and practices for ensuring the safety of tissue intended for trans- planatation and be able to demonstrate that the additional information collection requirements contained in the interim final regulation are the least burdensome necessary and that they have practical utility. Finally, we note that the agency violated the Paperwork Reduction Act by failing to submit the information collection requirements contained in the interim final rule until three months after the promulgation of the rule. (See 5 CFR 1320.13).
  Inventory as of this Action Requested Previously Approved
08/31/1995 08/31/1995
400 0 0
4,616 0 0
0 0 0

FDA ISSUED AN INTERIM RULE REQUIRING CERTAIN INFECTIOUS DISEASE TESTING, DONOR SCREENING, AND RECORDKEEPING TO HELP PREVENT THE TRANSMISSION OF AIDS AND HEPATITIS THROUGH HUMAN TISSUE USED IN TRANSPLANTATION.

None
None


No

1
IC Title Form No. Form Name
HUMAN TISSUE INTENDED FOR TRANSPLANTATION -- 21 CFR 1270

  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 400 0 0 400 0 0
Annual Time Burden (Hours) 4,616 0 0 4,616 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
03/11/1994


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