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
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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.
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.