LABELING REQUIREMENTS FOR MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS

ICR 198404-0910-002

OMB: 0910-0195

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0195 198404-0910-002
Historical Active
HHS/FDA
LABELING REQUIREMENTS FOR MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 05/23/1984
Retrieve Notice of Action (NOA) 04/04/1984
APPROVED. SUBJECT TO THE CONDITIONS ESTABLISHED IN BEDELL TO SERMIER LETTER OF 5/24/84.
  Inventory as of this Action Requested Previously Approved
05/31/1985 05/31/1985
4,400 0 0
325,382 0 0
0 0 0

LABELING REQUIREMENTS ARE DESIGNED TO SPECIFY WHAT INFORMATION IS NEEDED ON THE LABEL IN ORDER FOR MANUFACTURERS TO COMPLY WITH THE STATUTE.

None
None


No

1
IC Title Form No. Form Name
LABELING REQUIREMENTS FOR MEDICAL DEVICES AND RADIOLOGICAL PRODUCTS

  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 4,400 0 0 0 4,400 0
Annual Time Burden (Hours) 325,382 0 0 0 325,382 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.
04/04/1984


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