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

Forms and Documents

Document Name	Status
0614 SNS ss 5-7-08.doc Supporting Statement A	2008-05-07

IC Document Collections

IC ID	Document Title	Status
184882	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	New
182815	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Modified
182814	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Modified
182813	Exceptions Or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile	Modified

ICR Details

OMB Control No: 0910-0614	ICR Reference No: 200805-0910-006
Status: Historical Active	Previous ICR Reference No: 200805-0910-005
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: 06/13/2008
	Date Received in OIRA: 05/13/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved	06/30/2008
Responses	31	0	30
Time Burden (Hours)	728	0	720
Cost Burden (Dollars)	0	0	0

---

Abstract: 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).

---

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	72 FR 73589	12/28/2007

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

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
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	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

---

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

---

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: 05/13/2008

---