Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile

ICR 200805-0910-006

OMB: 0910-0614

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2008-05-07
ICR Details
0910-0614 200805-0910-006
Historical Active 200805-0910-005
HHS/FDA
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Extension without change of a currently approved collection   No
Regular
Approved without change 06/13/2008
Retrieve Notice of Action (NOA) 05/13/2008
  Inventory as of this Action Requested Previously Approved
06/30/2011 36 Months From Approved 06/30/2008
31 0 30
728 0 720
0 0 0

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).

PL: Pub.L. 107 - 188 121 Name of Law: PHS and Bioterrorism Preparedness and Response Act
   US Code: 42 USC 247d-6b Name of Law: PHS Act
   US Code: 21 USC 352 Name of Law: FFDCA
  
None

0910-AF90 Final or interim final rulemaking 72 FR 73589 12/28/2007

No

  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 31 30 0 1 0 0
Annual Time Burden (Hours) 728 720 0 8 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
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.
05/13/2008


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