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.
table that charts list comparision
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
Reginfo record details
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