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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:
201104-0910-013
Status:
Historical Active
Previous ICR Reference No:
200805-0910-006
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:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/12/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/29/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2014
36 Months From Approved
08/31/2011
Responses
3
0
31
Time Burden (Hours)
56
0
728
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection request covers certain reporting requirements associated with labeling requirements for the Strategic National Stockpile.
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:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
75 FR 74062
11/30/2010
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 23819
04/28/2011
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i)
201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i)
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 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
3
31
0
-12
-16
0
Annual Time Burden (Hours)
56
728
0
-288
-384
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The negative numbers that appear in the 'Due to Agency Discretion' and 'Due to Adjustment in Agency Estimate' column are due to: #1: The estimated total annual burden for this information collection was 728 hours in 2007. The current decrease to 56 burden hours is attributed to the number of annual submissions received since the regulations became effective. #2: the electronic database systems - ICRAS and ROCIS (used by the Department of Health and Human Services (HHS) and Office of Management and Budget (OMB) automatically defaults the deleted Information Collection (IC) line items into the 'Due to Agency Discretion' column. Once an Information Collection (IC) line item is deleted, the electronic database systems, used by HHS and OMB, does not allow FDA to modify without the 'annual number of responses and 'annual hour burden' automatically defaulting to a program change and causing a negative number. The negative numbers are a result of the database systems keeping a record of all information since 2007.
Annual Cost to Federal Government:
$4,200
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]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov
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:
04/29/2011
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