Bar Code Label Requirements for Human Drug Products and Biological Products

Forms and Documents

Document Name	Status
0537 SUPPORTING STATEMENT FINAL 5-30-13.doc Supporting Statement A	2013-05-30

IC Document Collections

IC ID	Document Title	Status
6254	Bar Code Label Requirements - 21 CFR 201.25(d)	Modified

ICR Details

OMB Control No: 0910-0537	ICR Reference No: 201306-0910-001
Status: Historical Active	Previous ICR Reference No: 201005-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: 19665
Title: Bar Code Label Requirements for Human Drug Products and Biological Products
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: 08/06/2013
	Date Received in OIRA: 06/05/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	08/31/2013
Responses	2	0	2
Time Burden (Hours)	48	0	48
Cost Burden (Dollars)	0	0	0

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Abstract: FDA regulations at 21 CFR 201.25 requires bar codes on the labels of most human prescription drug products and on certain OTC drug products. Most of the information collection resulting from this regulation is covered under existing OMB control numbers. This ICR only requests OMB approval for waiver requests from the bar code requirement. A request that FDA waive the bar code requirement for a particular drug product must include the following information: (1) Compliance with the bar code requirement would adversely affect the safety, effectiveness, purity, or potency of the drug or not be technologically feasible, and the concerns underlying the request could not reasonably be addressed by measures such as package redesign or use of overwraps; or (2) an alternative regulatory program or method of product use renders the bar code unnecessary for patient safety.

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Authorizing Statute(s): US Code: 21 USC 358, 360, 360b, 360j Name of Law: null
   US Code: 21 USC 331, 351-355 Name of Law: null
   US Code: 21 USC 360gg-360ss, 371, 374, 379e Name of Law: null
   US Code: 42 USC 216,241,262,263a,264 Name of Law: null
   US Code: 21 USC 321 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:
	77 FR 48818	08/17/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 28856	05/16/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Bar Code Label Requirements - 21 CFR 201.25(d)

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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)	48	48	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: $0

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: 06/05/2013

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