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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0614
ICR Reference No:
200711-0910-007
Status:
Historical Inactive
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Preapproved
Conclusion Date:
12/13/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/20/2007
Terms of Clearance:
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
Expiration Date
06/30/2008
36 Months From Approved
Responses
30
0
0
Time Burden (Hours)
720
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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).
Authorizing Statute(s):
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
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AF90
Final or interim final rulemaking
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
ICR Summary of Burden
Total Request
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
30
0
0
30
0
0
Annual Time Burden (Hours)
720
0
0
720
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
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.
Annual Cost to Federal Government:
$36,600
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
11/20/2007
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