Agreement for Shipments of Devices for Sterilization

ICR 201004-0910-006

OMB: 0910-0131

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2010-04-15
IC Document Collections
IC ID
Document
Title
Status
5746
Modified
ICR Details
0910-0131 201004-0910-006
Historical Active 200702-0910-004
HHS/FDA
Agreement for Shipments of Devices for Sterilization
Extension without change of a currently approved collection   No
Regular
Approved without change 08/13/2010
Retrieve Notice of Action (NOA) 04/26/2010
  Inventory as of this Action Requested Previously Approved
08/31/2013 36 Months From Approved 08/31/2010
1,800 0 1,800
8,100 0 8,100
0 0 0

The FDA has the statutory authority under section 510(a)(2),(c), and (e) of the Federal, Food, Drug, and Cosmetic Act, nonsterile devices which are labeled as sterile but are in interstate transit a facility to be sterilized are adulterated and misbranded. In some cases, it is necessary for firms to manufacture and label medical devices as sterile at one establishment and to ship the devices as sterile at one establishment and to ship the devices in interstate commerce for sterilization at another establishment.

Statute at Large: 21 Stat. 351 Name of Statute: null
   Statute at Large: 21 Stat. 352 Name of Statute: null
  
None

Not associated with rulemaking

  75 FR 7276 02/18/2010
75 FR 21631 04/26/2010
No

1
IC Title Form No. Form Name
Agreement for Shipments of Devices for Sterilization

  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 1,800 1,800 0 0 0 0
Annual Time Burden (Hours) 8,100 8,100 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$3,881
No
No
No
Uncollected
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
04/26/2010


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