Public Health Service Act (the PHS
Act) (42 U.S.C. 247d-6b) , this collection of medical products for
use during national health emergencies, known as the Strategic
National Stockpile (SNS), is to "provide for the emergency health
security of the United States, including the emergency health
security of children and other vulnerable populations, in the event
of a bioterrorist attack or other public health emergency." It may
be appropriate for certain medical products that are or will be
held in the SNS to be labeled in a manner that would not comply
with certain FDA labeling regulations, given their anticipated
circumstances of use in an emergency. However, noncompliance with
these labeling requirements could have rendered such products
misbranded under section 502 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 352).
The estimated total annual
burden for this information collection was 720 hours in 2007. The
current increase to 728 burden hours is attributed to the response
to the public comment to account for any additional labeling
changes not already covered by FDA regulations.
$36,600
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Jonnalynn Capezzuto
3018274659
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.