Medical Device Labeling Regulations

ICR 200806-0910-006

OMB: 0910-0485

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-06-20
IC Document Collections
IC ID
Document
Title
Status
6187
Modified
ICR Details
0910-0485 200806-0910-006
Historical Active 200504-0910-002
HHS/FDA
Medical Device Labeling Regulations
Extension without change of a currently approved collection   No
Regular
Approved without change 08/01/2008
Retrieve Notice of Action (NOA) 06/27/2008
  Inventory as of this Action Requested Previously Approved
08/31/2011 36 Months From Approved 07/31/2008
2,386,987 0 2,320,385
3,620,102 0 3,503,120
0 0 0

Manufacturers, packers, and distributors of medical devices are required to assure that the labeling of the device includes adequate directions for use according to whether the device is inended for use by health care professionals or lay persons.

None
None

Not associated with rulemaking

  72 FR 21959 04/23/2008
73 FR 36534 06/27/2008
No

1
IC Title Form No. Form Name
Medical Device Labeling Regulations

  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 2,386,987 2,320,385 0 0 66,602 0
Annual Time Burden (Hours) 3,620,102 3,503,120 0 0 116,982 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,800,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Denver Presley 3018271462

  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.
06/27/2008


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