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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
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