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

Forms and Documents

Document Name	Status
0910-0614_-_Supporting_Statement_A_-_1_18_2011.doc Supporting Statement A	2011-04-28

IC Document Collections

IC ID	Document Title	Status
184882	201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i)	Modified
182815	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Removed
182814	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Removed
182813	201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), 21CFR809.11(b)(1)(i)	Modified

ICR Details

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
	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

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Abstract: This information collection request covers certain reporting requirements associated with labeling requirements for the Strategic National Stockpile.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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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.

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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

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Common Form ICR:  No

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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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