Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements; Proposed Rule

ICR 200603-0910-004

OMB: 0910-0585

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0585 200603-0910-004
Historical Inactive
HHS/FDA
Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements; Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 05/04/2006
Retrieve Notice of Action (NOA) 03/09/2006
This information collection associated with the proposed rule on "Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements" are not approved at this time. FDA shall examine public comment in response to the NPRM and will describe in the preamble of the final rule how the agency has maximized the practical utility of the collection and minimized the burden. For any future submissions of this information collection, FDA shall indicate the submission as "new" and reference OMB control number 0910-0585 (see OMB Form 83-I, items 1 and 2).
  Inventory as of this Action Requested Previously Approved
0 0 0
0 0 0
0 0 0

The proposed requirements are intended to do the following: Make the contents of medical gas containers more readily identifiable, reduce the likelihood that containers of industrial or other gases would be inappropriately connected to medical oxygen supply systems, and reduce the risk of contamination of medical gases.

None
None


No

1
IC Title Form No. Form Name
Medical Gas Containers and Closures: Current Good Manufacturing Practice Requirements; Proposed Rule

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.
03/09/2006


© 2024 OMB.report | Privacy Policy