This information
collection request is pre-approved for six months pursuant to the
emergency submission procedures of the PRA. FDA will update ROCIS
with the publication date of the associated interim final rule to
activate this approval and will publish the OMB number of this
collection in the information collection requirements section of
the rule's preamble. Within the six month approval period, FDA will
follow the normal public comment procedures of the PRA to obtain a
standard approval.
Inventory as of this Action
Requested
Previously Approved
06/30/2008
36 Months From Approved
30
0
0
720
0
0
0
0
0
Under the Public Health Security and
Bioterrorism Preparedness and Response Act and other relevant
statutes, the Department of Health and Human Services (HHS)
stockpiles medical products that are essential to the security of
the nation (see Public Law 107-188, Title I, section 121 (June 12,
2002)). As established in section 3 of the Project BioShield Act of
2004 (section 319F-2 of the 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 interim final rule
would allow the appropriate FDA Center Director to grant an
exception or alternative to certain FDA labeling requirements if
compliance with the requirements could adversely affect the safety,
effectiveness, or availability of products that are or would be in
the SNS. An exception or alternative granted under this rule may
include conditions or safeguards so that the labeling for such
products includes appropriate information necessary for the safe
and effective use of the product given the product's anticipated
circumstances of use. This rule would facilitate the safety,
effectiveness, and availability of appropriate medical
countermeasures and in the event of a public health emergency. If
the request is granted, the manufacturer may need to report to FDA
any resulting changes to the new drug application (NDA), biologics
license application (BLA), premarket approval application (PMA), or
premarket notification (510(k)) in effect, if any. The submission
and grant of a request for an exception or alternative to the
labeling requirements specified in this rule may be used to satisfy
certain reporting obligations relating to changes to product
applications under section 314.70 (21 CFR 314.70) (human drugs),
section 601.12 (21 CFR 601.12) (biological drugs), section 814.39
(21 CFR 814.39) (medical devices subject to premarket approval), or
section 807.81 (21 CFR 807.81) (medical devices subject to
premarket notification submission (510(k) clearance)
requirements).
This interim final rule
contains a new collection of information that would allow the
appropriate FDA Center Director to grant an exception or
alternative to certain FDA labeling requirements if compliance with
the requirements could adversely affect the safety, effectiveness,
or availability of products that are or would be in the SNS. An
exception or alternative granted under this rule may include
conditions or safeguards so that the labeling for such products
includes appropriate information necessary for the safe and
effective use of the product given the product's anticipated
circumstances of use. This rule would facilitate the safety,
effectiveness, and availability of appropriate medical
countermeasures and in the event of a public health emergency.
$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.
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile