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

Forms and Documents

Document Name	Status
0614 SS for 2017 Extension.pdf Supporting Statement A	2017-08-18

IC Document Collections

IC ID	Document Title	Status
184882	[Changes:] 201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), and 21CFR809.11(b)(1)(i)	Modified
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: 201706-0910-018
Status: Historical Active	Previous ICR Reference No: 201407-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
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: 11/14/2017
	Date Received in OIRA: 08/18/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2020	36 Months From Approved	11/30/2017
Responses	2	0	2
Time Burden (Hours)	32	0	32
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports Food and Drug Administration (FDA) regulations regarding Exceptions or Alternatives to Labeling Requirements for Products Held By the Strategic National Stockpile (SNS). The appropriate FDA Center Director may 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 will be included 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 facilitates the safety, effectiveness, and availability of appropriate medical countermeasures in the event of a public health emergency.

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Authorizing Statute(s): US Code: 42 USC 201 et seq. Name of Law: PHS Act
   US Code: 21 USC 301 et seq. Name of Law: FFDCA
   PL: Pub.L. 107 - 188 121 Name of Law: PHS and Bioterrorism Preparedness and Response Act
  

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:
	82 FR 23584	05/23/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 37101	08/08/2017
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)
[Changes:] 201.26(b)(1)(i), 21CFR610.68(b)(1), 21CFR801.128(b)(1)(i), and 21CFR809.11(b)(1)(i)

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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	2	2	0	0	0	0
Annual Time Burden (Hours)	32	32	0	0	0	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: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $2,800

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/18/2017

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