0537 SS Bar Code Exemption 2016

Bar Code Label Requirement for Human Drug Products
and Biological Products
OMB Control No. 0910-0537
Supporting Statement
A.

Justification

1. Circumstances Making the Collection of Information Necessary
In the Federal Register of February 26, 2004 (69 FR 9120), FDA issued a final rule entitled “Bar
Code Label Requirement for Human Drug Products and Blood” that requires human drug
product and biological product labels to have bar codes. Specifically, the rule requires bar codes
on most human prescription drug products and on over-the-counter (OTC) drug products that are
dispensed pursuant to an order and commonly used in health care facilities. The rule also
requires machine-readable information on blood and blood components. For human prescription
drug products and OTC drug products that are dispensed pursuant to an order and commonly
used in health care facilities, the bar code must contain the NDC number for the product. For
blood and blood components, the rule specifies the minimum contents of the label in a format
that is machine-readable and approved for use by the Director, Center for Biologics Evaluation
and Research. We believe the rule helps to reduce the number of medication errors in hospitals
and other health care settings by allowing health care professionals to use bar code scanning
equipment to verify that the right drug (in the right dose and right route of administration) is
being given to the right patient at the right time.
While most of the information collection burdens created by the final rule have now been
incorporated into currently approved information collections supporting the applicable
regulations, respondents to the collection may continue to seek an exemption from the bar code
label requirement under 21 CFR 201.25(d). Section 201.25(d) requires submission of a written
request for an exemption and describes the information that must be included in such a request.
Accordingly, we are requesting OMB approval of the information collection provisions under 21
CFR 201.25(d).
2. Purpose and Use of the Information Collection
FDA will use information from respondents to determine whether an exemption from the bar
code labeling requirements may be granted to respondent.
3. Use of Improved Information Technology and Burden Reduction
The collection of information neither requires nor prohibits the use of automated, electronic,
mechanical, or other technological collection techniques.

4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of any duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
While the information collection applies to small and large businesses alike, FDA provides small
business and industry assistance to respondents through the Center for Drug Evaluation and
Research (CDER) and through the Division of Manufacturers Assistance and Training
component in the Center for Biologics Evaluation and Research (CBER).
6. Consequences of Collecting the Information Less Frequently
Information collection occurs only upon respondent request for agency action.
7. Special Circumstances Relating to the Guidelines in 5 CFR 1320.5
There are no special circumstances for this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment in the
Federal Register of December 15, 2015. No comments were received.
9. Explanation of Any Payment or Gift to Respondents
No payments or gifts are provided to respondents.
10. Assurance of Confidentiality Provided to Respondents
Records that may be reviewed during FDA inspections are subject to FDA regulations in 21 CFR
Part 20. Confidential commercial information is protected from disclosure under FOIA in
accordance with section 552(a) and (b) (5 U.S.C. 552(a) and (b)) and by part 20. To the extent
that § 20.64 applies, we will honor the confidentiality of any data in investigation records
compiled for law enforcement purposes.
11.

Justification for Sensitive Questions

The information collection does not contain questions of a sensitive nature.

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12.

Estimates of Annualized Hour Burden and Costs
12a. Annualized Hour Burden Estimate

FDA estimates it receives 2 exemption requests annually and that each exemption request
requires 24 hours to complete. This results in an annual reporting burden of 48 hours, as
reflected in Table 1 below.
Table 1 – Estimated Annual Reporting Burden
21 CFR Section

Exemption from bar code
requirement; 201.25(d)

No. of
Respondents

Responses
per
Respondent

Total
Annual
Responses

2

1

2

Burden
per
Respons
e
24

Total
Hours

48

There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Annualized Cost Burden Estimates
Type of Respondent
Pharmaceutical/Biological

Total Burden Hours
48

Hourly Wage
Rate
$75.00

Total Respondent
Costs
3,600

13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
Because of the small number of exemption requests filed under the regulation and because the
activity may be performed in conjunction with associated product review activities, we estimate
no annual cost to the Federal government.
15. Explanation for Program Changes or Adjustments
The burden for the information collection is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
Information collected under this requirement will not be published.

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17. Exemption for Display of Expiration Date
The agency does not seek an exemption from displaying the expiration date.
18. Exceptions to Certification for Paperwork Reduction Act Submission
There are no exceptions to the certification.

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